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Regulatory Affairs Manager Remote Jobs (NOW HIRING)

Dentsply Sirona

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day ...

Dentsply Sirona, Inc

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day ...

Radiology Partners

Regulatory Affairs Manager

$125K - $150K/yr

General information Press space or enter keys to toggle section visibility Job Title Regulatory Affairs Manager Functional Area Teammate - Legal City Remote Work Location Type Remote State Remote ...

Dentsply Sirona, Inc

Regulatory Affairs Manager

This position can be a remote working arrangement. Candidates must be located in the US, ideally in ... Manages day to day activities for less senior Regulatory Affairs professionals, including but not ...

Symmetrio

Regulatory Affairs Manager-US

Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k ...

radiology partners

Regulatory Affairs Manager

$125K - $150K/yr

Remote Work Location Type: Remote WHO WE ARE AND WHAT WE DO: Radiology Partners, through its ... Manage incident reporting, recalls, labeling, and global regulatory expansion efforts DESIRED ...

Zimmer, Inc.

Regulatory Affairs Manager

What You Can Expect Responsible for managing support of regulatory affairs systems used to support ... While this is a remote position, strong preference will be given to candidates located in or near ...

Radiology Partners

Regulatory Affairs Manager

$125K - $150K/yr

Manage incident reporting, recalls, labeling, and global regulatory expansion efforts DESIRED ... Flexible Remote Schedules Nashville, TN preferred, not required * Generous PTO Plans and Paid ...

Argenta

Senior Regulatory Affairs Manager

Shawnee, KS · Remote

Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO ... The position is a remote position working out of your home with domestic and occasionally ...

Argenta

Senior Regulatory Affairs Manager

Shawnee, KS · Remote

Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO ... The position is a remote position working out of your home with domestic and occasionally ...

Jade Biosciences

$135K - $150K/yr

Role Overview The Regulatory Affairs Manager supports the development and execution of regulatory ... Position Location This is a remote role; periodic travel to team and company events is required.

Oscar Health

Analyst, Regulatory Affairs

Atlanta, GA · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... You will report into the Regulatory Manager. Work Location: This is a remote position, open to ...

Oscar Health

Analyst, Regulatory Affairs

Dallas, TX · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... You will report into the Regulatory Manager. Work Location: This is a remote position, open to ...

Oscar Health

Analyst, Regulatory Affairs

Dallas, TX · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... You will report into the Regulatory Manager. Work Location: This is a remote position, open to ...

Oscar Health

Analyst, Regulatory Affairs

Atlanta, GA · Remote

$28.30 - $37.15/hr

We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team. Oscar is the first ... You will report into the Regulatory Manager. Work Location: This is a remote position, open to ...

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How much do regulatory affairs manager remote jobs pay per hour?

As of Jul 19, 2026, the average hourly pay for regulatory affairs manager remote in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are often senior executive positions such as Director of Regulatory Affairs or Vice President of Regulatory Affairs, which can earn six-figure salaries. These roles typically require extensive experience, advanced certifications, and leadership skills in managing compliance and regulatory strategies across organizations.

Will AI replace regulatory affairs?

AI is increasingly used to support regulatory affairs managers by automating data analysis, document review, and compliance tracking. However, human expertise remains essential for interpreting regulations, making strategic decisions, and ensuring ethical considerations, so AI is more of a tool than a replacement in this field.

Can regulatory affairs jobs be done remotely?

Regulatory Affairs Managers can often perform their duties remotely, especially with the increasing use of digital tools for document review, compliance tracking, and communication with regulatory agencies. Remote work arrangements depend on company policies, the need for in-person inspections or meetings, and the specific regulatory environment, but many roles in this field are now flexible and support telecommuting.

How does a Regulatory Affairs Manager working remotely typically collaborate with cross-functional teams to ensure compliance?

As a remote Regulatory Affairs Manager, you will regularly interact with cross-functional teams such as R&D, Quality Assurance, Clinical, and Marketing through virtual meetings, email, and collaborative project management tools. Effective communication and proactive coordination are key, as you may need to clarify regulatory requirements, review submission documents, and provide compliance guidance across different time zones. Building strong relationships and maintaining clear documentation helps facilitate seamless collaboration, ensuring all stakeholders are aligned on regulatory expectations and deadlines.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Manager (Remote), and why are they important?

To excel as a Regulatory Affairs Manager (Remote), you need a deep understanding of regulatory guidelines, compliance procedures, and industry standards, typically supported by a degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and certifications like RAC (Regulatory Affairs Certification) are highly valuable. Outstanding organizational skills, attention to detail, and strong communication abilities help you effectively interpret regulations and collaborate across teams. These competencies ensure products meet legal requirements efficiently, minimizing risks and facilitating successful market access.

What does a Regulatory Affairs Manager do when working remotely?

A Regulatory Affairs Manager working remotely is responsible for ensuring that their company's products comply with all relevant regulations and standards set by governmental and regulatory bodies. They prepare and submit documentation, monitor changes in regulations, and communicate with regulatory agencies to facilitate product approvals or renewals. While remote, they use digital tools to collaborate with internal teams, manage compliance projects, and stay updated on industry changes. Their work ensures that products remain in the market legally and safely.

What is the difference between Regulatory Affairs Manager Remote vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Manager RemoteRegulatory Affairs Specialist
CredentialsBachelor's degree, often advanced certifications (RAC)Bachelor's degree, some certifications preferred
Work EnvironmentRemote, managerial oversight, strategic planningRemote or on-site, focused on document preparation and compliance
Industry UsageUsed across pharmaceutical, biotech, medical device companiesCommon in similar industries, often reporting to managers
Search & Comparison IntentUnderstanding managerial roles and responsibilitiesFocus on entry to mid-level regulatory tasks

The Regulatory Affairs Manager Remote oversees regulatory strategies and compliance at a managerial level, often requiring advanced certifications. The Regulatory Affairs Specialist handles specific regulatory tasks, such as preparing documentation and ensuring compliance, typically with less managerial responsibility. Both roles are essential in regulated industries like pharma and biotech, with the manager focusing on strategy and leadership, while the specialist executes detailed regulatory activities.

Which is better, QA or RA?

For a Regulatory Affairs (RA) Manager, both QA (Quality Assurance) and RA are essential but serve different functions; QA focuses on product quality and compliance processes, while RA ensures regulatory compliance and approval for markets. The choice depends on career interests—QA emphasizes process improvement and testing, whereas RA involves understanding regulations and documentation. Both roles often require knowledge of industry standards and certifications, and they can complement each other in regulated industries.
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Regulatory Affairs Manager Remote jobs near you
Infographic showing various Regulatory Affairs Manager Remote job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 76% Full Time, 20% Part Time, 1% Temporary, and 2% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.
Regulatory Affairs Manager

Regulatory Affairs Manager

Dentsply Sirona

Remote

Full-time

Posted 18 days ago

Dentsply Sirona rating

6.3

Company rating: 6.3 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

Requistion ID: 83800
Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.
Dentsply Sirona's products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona's headquarter is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.
This position can be a remote working arrangement. Candidates must be located in the US, ideally in the eastern time zone.
Job Summary:
The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
  • Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
  • Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
  • Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
  • Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
  • Coordinates regulatory activities with internal teams and external regulatory agencies.
  • Reviews and approves product labelling and claims for the US and EU markets.
  • Stays current with regulatory requirements and updates affected policies and procedures.
  • Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
  • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
  • Complies with company and departmental policies and administrative requirements.
  • Performs other duties as assigned or as needed.

Education:
  • Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
  • Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.

Years and Type of Experience:
  • 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
  • Experience with leading regulatory submissions and managing regulatory projects.
  • In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
  • Experience with software as a medical device, AI and/or medical devices containing software is a plus

Required Computer / Software Skills:
  • Proficiency with Microsoft Office Suite
  • Proficiency with Regulatory software

Key Required Skills, Knowledge, and Capabilities:
  • Strong leadership, project management, and organizational skills including attention to detail.
  • Strong written and verbal communication skills.
  • Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
  • Excellent interpersonal skills.
  • Ability to work effectively in a team environment and independently.
  • Knowledge of regulatory affairs principles and practices.
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
  • Willingness to learn and adapt to new processes and technologies.
  • Leadership experience within medical device organizations.

Key Leadership Behaviors:
  • Actively articulates and promotes Dentsply Sirona's vision and direction.
  • Advocates on behalf of the customer.
  • Values driven with an insistence on excellence.
  • Promotes high performance, innovation, and continual improvement.
  • Consistently meets Company standards, ethics, and compliance requirements.
  • Strong results orientation and analytical skills.
  • Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
  • Resolves conflicts and fosters a positive working environment.

The base salary and target annual incentive for this remote role is between $154,000 - $165,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.
Eligibility: All successful applicants must be eligible to work in the country the position is based.
Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to accommodationrequest@dentsplysirona.com.
Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.
Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com.

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