Regulatory Affairs Specialist (FDA/Medical Device)

Job Title:

Regulatory Affairs Specialist (FDA/Medical Device)

Location:

Torrance, CA Type:

Full-time (On-site)

Schedule:

9:00 AM - 6:00 PM (Offers flexibility in occasions for your needs to take care of your family members or academic commitment) Role Overview An established consulting firm in Torrance, serving a prestigious roster of international clients in the medical device and pharmaceutical sectors, are looking for a Regulatory Affairs Specialist who values precision, professionalism, and long-term career growth. This role requires high-level coordination between US regulatory bodies (FDA, EPA) and our client base. The ideal candidate is not just a scientist, but a disciplined professional who thrives in a structured, collaborative, and detail-oriented environment.

Key Responsibilities Regulatory Submission Management:

Meticulously compile and organize technical documentation for 510(k), PMA, De Novo, and Annual Reports, ensuring zero errors in compliance.

Structured Reporting:

Provide frequent, detailed status updates to management and clients; synthesize complex data into clear, formal business reports.

Client Liaison:

Act as a respectful and professional representative when communicating with government agencies and corporate clients to facilitate product approvals.

Strategic Research:

Conduct exhaustive research on FDA/EPA regulations to support senior consultants in developing market entry roadmaps.

Team Support:

Assist in various administrative and operational tasks to support the team's success, demonstrating a "team-first" mentality. Professional Expectations (Cultural Fit) Meticulous Attention to

Detail:

You double-check your work naturally and take pride in accuracy. Respect for

Protocol:

You are comfortable working within established procedures and respect organizational hierarchy and decision-making processes.

Dedication:

You possess a strong work ethic and a willingness to be flexible with your schedule when critical deadlines or client needs arise.

Professional Etiquette:

You maintain a high level of formality and politeness in all written and verbal communications, suitable for interacting with executives and government officials.

Qualifications Education:

Bachelor's degree in a STEM field (Biology, Chemistry, Bioengineering, etc.) is required.

Experience:

Previous experience in a corporate or research environment; exposure to Medical Device/Pharma industries is a major plus.

Technical Skills:

Advanced proficiency in Microsoft Office (formatting in Word/Excel must be impeccable); ability to digest complex scientific literature.

Attributes:

Punctual, humble, and eager to learn from senior mentors.

Compensation & Benefits Salary:

Competitive Annual Salary (Based on experience).

Bonuses:

Annual Year-End Bonus + Monthly Performance Incentives.

Benefits:

Medical, Dental, and Vision insurance; 401(k) Retirement fund.