Top 183 Regulatory affairs specialist Jobs

Regulatory Affairs Specialist
elliquence, LLC —Baldwin, NY
- $75,000 - $85,000 a year
- Full-time
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Sr. Regulatory Affairs Specialist
Prismatik Dentalcraft —Irvine, CA
- $86,000 - $120,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Research
- Health insurance
- Dental insurance
Quick Apply
10d
Regulatory Affairs Specialist
Manpower Engineering —Trumbull, CT
- $30 - $36 an hour
- Hybrid work
- Mid-level
- Analysis skills
- Organizational skills
Quick Apply
4d
Senior Regulatory Affairs Specialist
Philips —Bothell, WA
- $105,000 - $168,000 a year
- Full-time
- 5 years
- Office
- Travel
- Health savings account
- Employee stock purchase plan
Regulatory Affairs Specialist
Infojini Inc —Trumbull, CT
- $30 - $35 an hour
- Contract
- Hybrid work
- Microsoft Excel
- Management
- Mid-level
- Work from home
Quick Apply
5d
Regulatory Affairs Specialist
Stryker —Bloomington, MN
- $76,100 - $126,900 a year
- Full-time
- Research
- Office
- Master's degree
- Health savings account
- AD&D insurance
Regulatory Affairs Specialist I
City of Hope —Remote
- $37.11 - $57.52 an hour
- Full-time
- Mid-level
- Master's degree
- Analysis skills
5d
Regulatory Affairs Specialist I
Getinge —Fraser, MI
- $75,280 - $94,100 a year
- Extended hours
- Microsoft Word
- Engineering
- Office
- Commuter assistance
- Disability insurance
Regulatory Affairs Specialist
Kelly Services —Des Plaines, IL
- $80,000 - $90,000 a year
- Full-time
- Hybrid work
- Writing skills
- Mid-level
- 3 years
- Paid holidays
- Disability insurance
Quick Apply
Regulatory Affairs Specialist
Cordialsa USA —The Woodlands, TX
- Full-time
- Hybrid work
- Spanish
- 5 years
- English
- Dental insurance
- Paid time off
Quick Apply
6d
Specialist, Regulatory Affairs
John Paul Mitchell Systems —Santa Clarita, CA
- $39.61 - $43.27 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
4d
Senior Regulatory Affairs Specialist
Medline Industries —Remote
- $92,000 - $138,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Databases
- Health insurance
- 401(k)
Regulatory Affairs Specialist - WHIRC
Henry M. Jackson Foundation —Annandale, VA
- $67,500 - $97,000 a year
- Full-time
- HIPAA
- Mid-level
- Health insurance
- Dental insurance
Sr. SW Compliance Specialist – Regulatory Affairs & Design Assurance
Meridian Bioscience, Inc. —Remote
- Full-time
- Microsoft Outlook
- Computer Science
- Bachelor of Science
Regulatory Affairs Specialist
TerrAscend —Remote
- $58,000 - $62,000 a year
- Full-time
- Remote
- Background check
- Microsoft Excel
- Microsoft Outlook
- Paid parental leave
- Disability insurance
Quick Apply
6d
Senior Regulatory Affairs Specialist
Nektar Therapeutics —Remote
- $150,000 - $185,000 a year
- Microsoft Word
- Bachelor's degree
- Organizational skills
- Employee stock purchase plan
- Paid holidays
Quality Assurance Regulatory Affairs Specialist
VERO BIOTECH INC —Atlanta, GA
- Full-time
- Mid-level
- High school diploma or GED
- Bachelor's degree
Quick Apply
Regulatory Affairs Specialist (Food Manufacturing)
Dessert Holdings Inc. —Humble, TX
- Overtime
- Mid-level
- Bachelor's degree
- 1 year
Quick Apply
Regulatory Affairs Specialist
Charter Medical, LLC —Winston-Salem, NC
- Monday to Friday
- Mid-level
- 3 years
- Communication skills
- Disability insurance
- Health insurance
Quick Apply
Regulatory Affairs Specialist
Prelude DX —Laguna Hills, CA
- $90,000 - $140,000 a year
- Monday to Friday
- 6 years
- Engineering
- Office

I want to receive the latest job alert for regulatory affairs specialist

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs specialist jobs near

Regulatory Affairs Specialist jobs in Trumbull, CT

Regulatory Affairs Specialist jobs in Remote

Regulatory Affairs Specialist jobs in Irvine, CA

Regulatory Affairs Specialist jobs in Atlanta, GA

Regulatory Affairs Specialist jobs in Santa Clarita, CA

Regulatory Affairs Specialist jobs in Des Plaines, IL

Regulatory Affairs Specialist jobs in Bothell, WA

Regulatory Affairs Specialist jobs in Mahwah, NJ

Regulatory Affairs Specialist jobs in Fremont, CA

Regulatory Affairs Specialist jobs in Londonderry, NH

Regulatory Affairs Specialist jobs in Holly Springs, NC

Student Support Specialist jobs in Minnesota

Regulatory Affairs jobs in San Francisco Bay Area, CA

Clinical Documentation Improvement Specialist jobs in Houston, TX

Regulatory Affairs Specialist jobs in Jersey City, NJ

Regulatory Affairs Specialist jobs in Fairfax, VA

Regulatory Affairs Specialist jobs in Chicago, IL

Regulatory Affairs Specialist jobs in Cypress, CA

Peer Support Specialist jobs in Orange County, CA

Veterans Affairs jobs in Remote

Regulatory Affairs Specialist

elliquence, LLC -
Baldwin, NY

Quick Apply

Job Details

Full-time
$75,000 - $85,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Medical device validation
Regulatory Affairs Certification (RAC)
Process improvement standards implementation
Regulatory compliance
Biomedical Engineering
Bachelor's degree
Health Science
Regulatory affairs
Biomedical regulatory compliance
Manufacturing

Full Job Description

About the job
This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.

Key Responsibilities:
Primary Responsibilities

Assist in the preparation, formatting, and collection of regulatory submissions
Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete.
Oversee inquiries into regulatory agency requests for additional information for document submission.
Support U.S. and EU market approval processes and ensure compliance with regulatory standards
Support post-market submissions (progress reports, annual reports, etc.)
Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.
Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.

Compliance & Quality System Support

Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
Support in audits (internal and external) in document preparation as needed.
Support document control and recordkeeping to ensure regulatory documentation integrity and traceability.
Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.

Cross-Functional Collaboration

Partner with Engineering and Clinical teams to gather information needed for submissions and documentation.
Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents.
Support training and awareness initiatives related to regulatory compliance.
Interpret new or existing regulations and ensure business practices align with compliance requirements.
Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership.
Establish and maintain regulatory information systems.
Contribute in continuous improvement initiatives and process optimization within Regulatory Affairs.

Qualifications:

Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred).
Master’s degree in related field can count towards 1 year of relevant experience.
3-5 years of experience in a regulated FDA environment (medical devices or combination products).
Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus). Strong knowledge in regulatory strategy and approval approaches.
Strong understanding of FDA and EU medical device regulations (international experience desirable).
Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred.
Audit experience as a contributor is preferred.
Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project’s success.
Strong organizational, communication (verbal and written), and planning skills.
Ability to interact cross functionally across multiple departments with various levels of the organization.
Detail oriented, practical and proactive problem solver.
Proficiency with PC systems and office applications.
Solid understanding of scientific principles applied to regulatory affairs.
Understanding of regulatory and business needs with ability to engage cross functional team members.

Salary range is $75,000- $85,000/annual USD

An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Ability to Commute:

Baldwin, NY 11510 (Required)

Ability to Relocate:

Baldwin, NY 11510: Relocate before starting work (Required)

Work Location: In person

Quick Apply

Refine Your Search

regulatory affairs specialist jobs

Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist

Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist I

Regulatory Affairs Specialist I

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Specialist, Regulatory Affairs

Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist - WHIRC

Sr. SW Compliance Specialist – Regulatory Affairs & Design Assurance

Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Quality Assurance Regulatory Affairs Specialist

Regulatory Affairs Specialist (Food Manufacturing)

Regulatory Affairs Specialist

Regulatory Affairs Specialist

I want to receive the latest job alert for regulatory affairs specialist

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected