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.