Administrative Skills, Artificial Intelligence (AI), Bioengineering, Biology, Biotech and Pharmaceutical, Chemistry, Consulting, Customer Relations, Detail Oriented, Environmental Protection Agency (EPA), FDA (Food and Drug Administration), FDA Requirements, Government, Medical Equipment, Mentoring, Microsoft Excel, Microsoft Office, Microsoft Word, Operational Support, Presentation/Verbal Skills, Procedure Development, Regulations, Regulatory Submissions, Research Skills, Team Player, Technical Writing, Time Management
Job Description:
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.
About Us
At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact.
Staffmark is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Staffmark offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Staffmark is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
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Staffmark Group Llc
We recognize that you have choices when it comes to staffing companies. What makes Staffmark different? We think it's our focus on two things: people and results. This focus has allowed Staffmark to create one of the top customer satisfaction programs in the staffing industry. Staffmark has earned Inavero’s Best of Staffing® Client Diamond Award after winning the Best of Staffing Client Award for the last seven years! Presented in partnership with CareerBuilder, Inavero’s Best of Staffing Client Diamond winners have proven to be industry leaders in service quality based completely on the ratings given to them by their clients. We are focused on matching jobs with people and people with jobs, so If you're looking for a job, we're looking for exceptional people, and we invite you to join us. If you're looking for exceptional talent, we invite you to put our team to work for you! Come see what it's like to work with a leader in the staffing industry.