Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, MDSAP ...
Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and ... Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, MDSAP ...
Regulatory Affairs Supervisor- REMOTE
Baltimore, MD · Remote
$80K - $100K/yr
Remote (U.S.-Based) - Any Location Employment Type: Full-Time Position Summary We are seeking an ... Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional ...
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Regulatory Affairs Supervisor- REMOTE
Baltimore, MD · Remote
$80K - $100K/yr
Remote (U.S.-Based) - Any Location Employment Type: Full-Time Position Summary We are seeking an ... Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional ...
This Position is Work form Home - Remote Position for All USA location only. We're looking for that ... Represent Compliance Group at various events. * Have a good understanding of the FDA regulations ...
This Position is Work form Home - Remote Position for All USA location only. We're looking for that ... Represent Compliance Group at various events. * Have a good understanding of the FDA regulations ...
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Ensure compliance with FDA, USDA/APHIS, Fish & Wildlife Service, and other PGA import requirements ...
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Ensure compliance with FDA, USDA/APHIS, Fish & Wildlife Service, and other PGA import requirements ...
Remote Regulatory Affairs contractor
Atlanta, GA · Remote
$99 - $100/hr
... compliance * Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) * Author, compile and deliver a complete 510k ...
Quick apply
Remote Regulatory Affairs contractor
Atlanta, GA · Remote
$99 - $100/hr
... compliance * Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) * Author, compile and deliver a complete 510k ...
... development compliance with ISO and the FDA with digital processes, electronic signatures, data ... This Position is Work form Home - Remote Position for All USA location only. What to expect We are ...
... development compliance with ISO and the FDA with digital processes, electronic signatures, data ... This Position is Work form Home - Remote Position for All USA location only. What to expect We are ...
Product Compliance & Nutrition Analyst: 26-01822
Austin, TX · On-site +1
$30 - $35/hr
Austin, TX (#LI-Remote) Pay Range: $30.00 - $35.00 Per Hour on W2 #LP Job Summary: This role ... Knowledge of FDA and USDA food labeling regulations. * Experience with regulatory compliance in the ...
Product Compliance & Nutrition Analyst: 26-01822
Austin, TX · On-site +1
$30 - $35/hr
Austin, TX (#LI-Remote) Pay Range: $30.00 - $35.00 Per Hour on W2 #LP Job Summary: This role ... Knowledge of FDA and USDA food labeling regulations. * Experience with regulatory compliance in the ...
Director of Labeling & Promotional Review
Pennington, NJ · On-site +1
$225K - $240K/yr
... FDA-compliant (OPDP), and aligned with corporate objectives. RESPONSIBILITIES: Ensure that ... Alternatively, this position may be remote, but from time to time or when required, the employee ...
Director of Labeling & Promotional Review
Pennington, NJ · On-site +1
$225K - $240K/yr
... FDA-compliant (OPDP), and aligned with corporate objectives. RESPONSIBILITIES: Ensure that ... Alternatively, this position may be remote, but from time to time or when required, the employee ...
Remote - Home Office Summary: Reporting to the Vice President, Clinical Affairs, the Senior Manager ... Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR ...
Remote - Home Office Summary: Reporting to the Vice President, Clinical Affairs, the Senior Manager ... Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR ...
Senior Manager, Clinical Compliance
Irvine, CA · On-site +1
$160K - $170K/yr
Remote - Home Office Summary: Reporting to the Vice President, Clinical Affairs, the Senior Manager ... Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR ...
Senior Manager, Clinical Compliance
Irvine, CA · On-site +1
$160K - $170K/yr
Remote - Home Office Summary: Reporting to the Vice President, Clinical Affairs, the Senior Manager ... Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR ...
Senior Program Director (Commercial Regulatory Affairs, Fully Remote)
South San Francisco, CA · Remote
$120 - $125/hr
South San Francisco, CA (Fully Remote) Duration: Long-Term Contract (Possibility Of Further ... Ensure compliance with FDA regulations and healthcare industry guidelines Qualifications:
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Senior Program Director (Commercial Regulatory Affairs, Fully Remote)
South San Francisco, CA · Remote
$120 - $125/hr
South San Francisco, CA (Fully Remote) Duration: Long-Term Contract (Possibility Of Further ... Ensure compliance with FDA regulations and healthcare industry guidelines Qualifications:
Technical Implementation Specialist - Mountain/Western Region
$100K - $125K/yr
FDA compliance experience is a plus * Deep experience with system installation and support ... Working knowledge of Wi-Fi, networking, remote access techniques, VPNs, firewalls * Familiarity ...
Technical Implementation Specialist - Mountain/Western Region
$100K - $125K/yr
FDA compliance experience is a plus * Deep experience with system installation and support ... Working knowledge of Wi-Fi, networking, remote access techniques, VPNs, firewalls * Familiarity ...
Life Sciences Ethics & Compliance Attorney
OR · Remote
$309K/yr
Remote (U.S.) We are seeking Ethics & Compliance Attorneys to join our Life Sciences team. In this ... Drafting responses to regulatory inquiries and supporting clients in preparation for FDA ...
Life Sciences Ethics & Compliance Attorney
OR · Remote
$309K/yr
Remote (U.S.) We are seeking Ethics & Compliance Attorneys to join our Life Sciences team. In this ... Drafting responses to regulatory inquiries and supporting clients in preparation for FDA ...
Required: (Remote Opportunity - Temp to Perm) The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and ...
Required: (Remote Opportunity - Temp to Perm) The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and ...
Hybrid - onsite and remote Hours: 40.0 Security Clearance: Overview Leave placeholder text here for ... NIS2, FDA cybersecurity expectations, industrial cybersecurity standards, or country?specific ...
Hybrid - onsite and remote Hours: 40.0 Security Clearance: Overview Leave placeholder text here for ... NIS2, FDA cybersecurity expectations, industrial cybersecurity standards, or country?specific ...
Risk Management Specialist - Fully Remote | Upto $1450 Part-time
New York, NY · Remote
$1.1K - $1.4K/wk
Regulatory Compliance & Risk Management Expert Type: Contract Compensation: $1,150-$1,450 per ... FFIEC , FDA , SEC , GDPR , HIPAA ) and risk frameworks ( COSO , ISO 31000 ). * Collaborate ...
Quick apply
Risk Management Specialist - Fully Remote | Upto $1450 Part-time
New York, NY · Remote
$1.1K - $1.4K/wk
Regulatory Compliance & Risk Management Expert Type: Contract Compensation: $1,150-$1,450 per ... FFIEC , FDA , SEC , GDPR , HIPAA ) and risk frameworks ( COSO , ISO 31000 ). * Collaborate ...
Associate Director Clinical Quality Assurance GCP
Gaithersburg, MD · On-site +1
$90 - $125/hr
... and FDA compliance for investigational late-stage/commercial cell therapy products ... The position is preferred to be based in Maryland with on-site access, but remote work is ...
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Associate Director Clinical Quality Assurance GCP
Gaithersburg, MD · On-site +1
$90 - $125/hr
... and FDA compliance for investigational late-stage/commercial cell therapy products ... The position is preferred to be based in Maryland with on-site access, but remote work is ...
... compliance with all federal and local agencies including the Food and Drug Administration (FDA) and ... This role is 100% remote ; however, we are only able to consider applicants who reside in one of ...
... compliance with all federal and local agencies including the Food and Drug Administration (FDA) and ... This role is 100% remote ; however, we are only able to consider applicants who reside in one of ...
Director of Mobile Product
$238K - $249K/yr
... remote care team to helping create the behavior change needed to adapt to hearing aids. This role ... Work closely with regulatory, ADK, GN R&D and others to ensure 510k FDA compliance. What you'll ...
Director of Mobile Product
$238K - $249K/yr
... remote care team to helping create the behavior change needed to adapt to hearing aids. This role ... Work closely with regulatory, ADK, GN R&D and others to ensure 510k FDA compliance. What you'll ...
Regulatory Coordinator II (Remote)
Los Angeles, CA · On-site +1
$34.24 - $58.21/hr
... compliance with all federal and local agencies including the Food and Drug Administration (FDA) and ... Qualifications This role is 100% remote ; however, we are only able to consider applicants who ...
Regulatory Coordinator II (Remote)
Los Angeles, CA · On-site +1
$34.24 - $58.21/hr
... compliance with all federal and local agencies including the Food and Drug Administration (FDA) and ... Qualifications This role is 100% remote ; however, we are only able to consider applicants who ...
Remote Fda Compliance information
See salary details
$50K - $59.8K
0% of jobs
$59.8K - $69.5K
0% of jobs
$69.5K - $79.3K
0% of jobs
$79.3K - $89.1K
1% of jobs
$89.1K - $98.9K
0% of jobs
$98.9K - $108.6K
0% of jobs
$108.6K - $118.4K
0% of jobs
$118.4K - $128.2K
0% of jobs
$128.2K - $138K
3% of jobs
$138K - $147.7K
0% of jobs
$149.8K is the 25th percentile. Wages below this are outliers.
$147.7K - $157.5K
96% of jobs
$50K
$157.5K
How much do remote fda compliance jobs pay per year?
What is the difference between Remote Fda Compliance vs Remote Quality Assurance Specialist?
| Aspect | Remote Fda Compliance | Remote Quality Assurance Specialist |
|---|---|---|
| Certifications | FDA regulations, GMP, ISO | ISO, GMP, Six Sigma |
| Work Environment | Regulatory departments, compliance teams | Quality departments, manufacturing sites |
| Industry Usage | Pharmaceuticals, biotech, medical devices | Manufacturing, pharmaceuticals, biotech |
Remote Fda Compliance focuses on ensuring products meet FDA regulations and standards, primarily working with regulatory documentation and audits. Remote Quality Assurance Specialists concentrate on maintaining product quality through process audits and standards compliance. While both roles require knowledge of GMP and ISO, Fda Compliance emphasizes regulatory adherence, whereas Quality Assurance centers on product quality assurance processes.
What are the key skills and qualifications needed to thrive as a Remote FDA Compliance Specialist, and why are they important?
How does working remotely as an FDA Compliance specialist affect communication and collaboration with cross-functional teams?
What is a Remote FDA Compliance specialist?

Senior Director, Internal Audit & Compliance
Westborough, MA • On-site, Remote
Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 10 days ago
Olympus Corporation Of The Americas rating
7.9
Based on 18 frontline employees who took The Breakroom Quiz
166th of 421 rated machine equipment manufacturers
Job description
Working Location: Massachusetts, Westborough; Nationwide
Workplace Flexibility: Remote
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers.
This is a global leadership role responsible for developing, leading, and continuously improving the company’s corporate and internal audit programs across all manufacturing, distribution, R&D, and support sites worldwide. This role ensures ongoing compliance with applicable global regulatory requirements, internal Quality Management System (QMS) standards, and industry best practices within the medical device industry. This role will lead global transformational change for Olympus Corporate Compliance.
This position leads a team of corporate audit professionals responsible for assessing site readiness, identifying compliance risks, driving sustainable corrective and preventive actions (CAPAs), and promoting a culture of quality and continuous improvement. The role serves as a strategic partner to Quality, Regulatory Affairs, Operations, and executive leadership to ensure inspection readiness and compliance excellence across the enterprise.
- Lead and oversee the global corporate audit program across all company sites and critical business functions.
- Own, development, deployment and continuous improvement of the corporate and internal audit quality system process.
- Establish and maintain risk-based corporate and internal audit strategies aligned with applicable global regulations and standards, including FDA, EU MDR/IVDR, ISO 13485, MDSAP, and other regional requirements.
- Direct planning, execution, reporting, and follow-up activities for corporate and internal quality audits.
- Evaluate site compliance to internal QMS requirements, regulatory expectations, corporate procedures, and industry standards.
- Drive enterprise-wide compliance transformation and inspection readiness and ensures sustained compliance across manufacturing, design, clinical, distribution, and post-market activities.
- Partner with site leadership and functional stakeholders to address identified gaps, implement effective CAPAs, and strengthen quality system maturity.
- Monitor and analyse inspection trends, systemic issues, and quality metrics to proactively identify compliance risks and opportunities for improvement.
- Provide strategic guidance and subject matter expertise during regulatory agency inspections and external audits.
- Develop standardized audit methodologies, tools, training programs, and governance processes to ensure consistency and effectiveness globally.
- Build and lead a high-performing global team of internal inspectors and audit professionals, fostering a culture of accountability, collaboration, and continuous improvement.
- Prepare and present corporate audit outcomes, compliance trends, and risk assessments to executive leadership and quality governance forums. Makes recommendations for changes.
- Maintain awareness of evolving global regulatory requirements and industry expectations to ensure ongoing program effectiveness.
Required:
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field required; advanced degree preferred.
- Minimum of 12 years of progressive experience required in Quality Assurance, Regulatory Compliance, or Quality Systems within the medical device or regulated healthcare industry.
- Significant experience required leading global quality audit or internal inspection programs in a multinational organization.
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR/IVDR, MDSAP, and other international regulatory frameworks.
- Demonstrated experience interacting with regulatory agencies and supporting external inspections.
- Proven leadership experience managing global teams and influencing senior stakeholders across complex organizations.
- Certified Lead Auditor or equivalent quality certification (ASQ CQA, CQE, or similar).
- Experience supporting remediation programs, compliance transformations, or quality system harmonization initiatives.
- Strong analytical, communication, organizational, and problem-solving skills.
- Familiarity with digital quality systems, audit analytics, and risk management methodologies.
- Ability to travel domestic and internationally as required based on business needs.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
-
Competitive salaries, annual bonus and 401(k)* with company match
-
Comprehensive medical, dental, vision coverage effective on start date
-
24/7 Employee Assistance Program
-
Free live and on-demand Wellbeing Programs
-
Generous Paid Vacation and Sick Time
-
Paid Parental Leave and Adoption Assistance*
-
12 Paid Holidays
-
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
-
Work-life integrated culture that supports an employee centric mindset
-
Offers onsite, hybrid and field work environments
-
Paid volunteering and charitable donation/match programs
-
Employee Resource Groups
-
Dedicated Training Resources and Learning & Development Programs
-
Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position is $144,541.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Compliance
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About Olympus Corporation of the Americas
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
10,000+ Employees
Headquarters location
Center Valley, PA, US
Year founded
1968