Regulatory Affairs Specialist

Trumbull, CT

Full-time $80,000.00 - $100,000.00

Posted 06/11/2025

Regulatory Affairs Specialist

Position Overview
The Regulatory Affairs Specialist will be responsible for ensuring that our products comply with all applicable regulations and standards. This role involves managing submissions to regulatory agencies, conducting risk assessments, and collaborating with various departments to ensure compliance throughout the product lifecycle.

Key Responsibilities

Prepare and submit regulatory documents to the FDA and other regulatory bodies.
Conduct thorough reviews of labeling and promotional materials for compliance.
Manage submission timelines and coordinate with teams to ensure timely submissions.
Perform risk assessments and develop strategies to mitigate regulatory risks.
Stay updated on global regulatory trends and changes in FDA regulations.
Assist in the preparation for audits and inspections by regulatory agencies.
Collaborate with R&D and Quality Assurance teams to ensure compliance with ISO standards and industry regulations.
Provide guidance on regulatory requirements for clinical trials and product changes.
Review technical documents and ensure accuracy in regulatory submissions.

Qualifications

Bachelor's degree in Life Sciences, Pharmacy, or a related field.
Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
In-depth knowledge of FDA regulations including 21 CFR Part 820 and 1271.
Experience with submission management and regulatory submissions to FDA.
Strong understanding of quality assurance processes and ISO standards such as ISO 9001.
Excellent technical writing skills and attention to detail.
Proven ability to work collaboratively in a cross-functional team environment.
Strong organizational skills and ability to manage multiple projects simultaneously.
Familiarity with clinical trial regulations and processes.

Benefits

Vacation/PTO

Medical

Dental

Vision

401k

Bonus

Relocation

Telecommute

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.

Additional ways to apply

Preferred Skills

Michael Montevideo is recruiting for this position and the positions below.
Email me to apply for this position

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Job ID: MM41-1856297

Employees will receive paid leave to the extent required by state or local law. This job was first posted by CyberCoders on 06/11/2025 and applications will be accepted on an ongoing basis until the position is filled or closed.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.