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Fda Openings Jobs (NOW HIRING)

Issa

Future Opening: Front Desk Associate

Waldorf, MD · On-site

$13.25 - $17.25/hr

The FDA is the first person a member or guest sees when they enter the gym, and the last person they see when they leave. Greeting existing and prospective members quickly and with a smile and warm ...

Issa

Future Opening: Front Desk Associate

Glen Burnie, MD · On-site

$13.75 - $17.75/hr

The FDA is the first person a member or guest sees when they enter the gym, and the last person they see when they leave. Greeting existing and prospective members quickly and with a smile and warm ...

Ironside Human Resources

Mammographer

Gallup, NM

Strong knowledge of breast anatomy, positioning techniques, and MQSA/FDA compliance standards with ... Surrounded by beautiful natural landscapes and wide-open spaces * Ideal setting for professionals ...

Fujifilm

Senior Submissions Coordinator

Durham, NC · On-site

S. FDA) and European regulatory agencies under the EU Medical Device Regulation (EU MDR ... Liaise with the HCUS RA/QA department to ensure that there is open communication and to assist with ...

Ironside Human Resources

Mammographer

Gallup, NM

Strong knowledge of breast anatomy, positioning techniques, and MQSA/FDA compliance standards with ... Surrounded by beautiful natural landscapes and wide-open spaces * Ideal setting for professionals ...

Air Liquide

Regulatory Specialist

Fairfield, NJ · On-site

R10094604 Regulatory Specialist (Open) Location: Fairfield, NJ (Seppic) - Sales - North America ... Compliance & FDA Oversight: Manage critical documentation, including FDA quality statements ...

Fujifilm

Senior Submissions Coordinator

Durham, NC · On-site

S. FDA) and European regulatory agencies under the EU Medical Device Regulation (EU MDR ... Liaise with the HCUS RA/QA department to ensure that there is open communication and to assist with ...

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Fda Openings information

What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.
What cities are hiring for Fda Openings jobs? Cities with the most Fda Openings job openings:
What states have the most Fda Openings jobs? States with the most job openings for Fda Openings jobs include:
What job categories do people searching Fda Openings jobs look for? The top searched job categories for Fda Openings jobs are:
Fda Openings jobs near you
Infographic showing various Fda Openings job openings in the United States as of June 2026, with employment types broken down into 86% Full Time, 4% Part Time, and 10% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

Senior Regulatory Affairs Specialist

Integer Holdings Corporation

Plymouth, MN • On-site

$113K - $165K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago

Key responsibilities

  • Develops US and International regulatory strategies for product submissions, including identifying needs for testing.

  • Prepares US and International submissions and works with government agencies or distributors to obtain product approval or clearance.

  • Reviews engineering change orders and assesses the effect of product changes on US and International regulatory strategy and submissions.

Integer Holdings rating

7.2

Company rating: 7.2 out of 10

Based on 39 frontline employees who took The Breakroom Quiz

337th of 527 rated manufacturers

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities
necessary to obtain and maintain regulatory approvals within the United States and International markets and
ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
Key Accountabilities and Responsibilities
1. Adheres to Integer's Core Beliefs and all safety and quality requirements.
2. Develops US and International regulatory strategies for product submissions, identifying needs for bench,
animal and clinical testing.
3. Provides strategic input. Participates on Product Development teams, providing a high level of experience in
regulatory, strategy, timelines, and direction.
4. Prepares US and International submissions and work with government agencies and/or distributors to obtain
product approval/clearance.
5. Serves as informational resource for all departments, assisting in keeping company informed of US and
International regulatory requirements. Ensures relevant International, ISO and FDA Export requirements are
met, as required and ensures accuracy of submission information.
6. Initiates FDA export approval requires and product release authorizations.
7. Reviews ECO's and assess effect of product changes on US and International regulatory strategy and
submissions per standard procedures.
8. Evaluates post-market incident reports and determine MDR requirements.
9. Assists with recall/retrieval documentation and other activities.
10. Develops and maintains regulatory status documents and submission procedures.
11. Identifies, investigates, evaluates and implements as appropriate new methodologies associated with product
quality and quality systems.
12. Performs other functions as required.
Job Requirements
Minimum Education: Bachelor's degree in a related field.
Minimum Experience: 7+ years of US and International medical device regulatory submission/approval
experience, to include FDA, MDD, PMDA, TGA, and TPD experience.
Specialized Knowledge:
Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all
applicable laws which regulate medical device manufacturers. Ability to work through
difficult issues with suppliers and customers.
Special Skills:
Strong communication and technical writing skills. Skill in management, precision
measurement, auditing, training, supplier/customer relations, FDA inspections, ISO
9000.
Other: Skill in working with computers and experience with spreadsheet and word-processing
software.
Salary range $113,025 - $165,770
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer's success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.
U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

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