OverviewManager / Principal / Senior Regulatory Affairs Specialist Location: San Jose, CA. Job Type: Full Time, on-site. But may consider a Hybrid mode for well-qualified candidates.
JOB DETAILS Must-have/Qualifications:
- Bachelor's Degree or related technical or scientific discipline. Master's degree in Regulatory preferred or RAPS certification.
- 5-10 years' experience in regulatory affairs within the medical device industry
- Strong experience in EU Regulations (Medical Device directives (93/42/EC) and EU MDRs) required
- Experience in FDA product submissions (IDE, PMA, 510k) required
- Experience in writing/maintaining CE Technical Files preferred
- Experience with ISO 13485:2016 and ISO 14971 required.
- Excellent problem solving, decision-making, and root cause analysis skills are required.
DUTIES & RESPONSIBILITIES
- Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
- Provide guidance and approval regarding regulatory strategies and approaches.
- Develop, Maintain and update regulatory documents such as technical files for CE
marking, device master records, GSPR checklist, risk analysis, and design history files.
- Participate and Support new product development teams to provide regulatory support to
- Represent regulatory affairs on engineering and R&D product development project teams
to ensure all regulatory requirements are met through the development process and defining the requirements for regulatory submissions of products on international and domestic markets.
- Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging and notifying regulatory agencies and NB of substantial changes.
- Support post market activities and reportability to regulatory agencies.
- Required to support communication with FDA and the Notified Body, preparing responses
to questions or deficiency letters from regulatory agencies.
- Support and implement transition plans to new MDR regulations
- Required to maintain MDR system and compliance once implemented
- Participate and represent regulatory affairs during FDA and NB site audits.
Austin Vita is acting as an Employment Agency in relation to this vacancy.
Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.