Senior Specialist, Regulatory Affairs
About The Position
Advanced Bionics is seeking a Senior Specialist, Regulatory Affairs to develop and execute regulatory strategies supporting product approvals and registrations across international markets, with a focus on the Asia-Pacific (APAC) region. This hybrid role requires experience with Class III medical devices, PMA submissions, and global regulatory requirements. The role collaborates with cross-functional teams throughout the product development lifecycle to ensure regulatory compliance, maintain product registrations, and support timely market approvals. The position is based in Valencia, California, with a team-customized hybrid work model requiring three days onsite. Travel is up to 10%. Remote or hybrid work requires internet connectivity of at least 200 Mbps download and 10 Mbps upload. The stated annual pay range is $100,320–$125,400; compensation varies by location, qualifications, and experience. The role is also commission- or bonus-eligible.
Requirements
- Bachelor's degree in a scientific discipline, engineering, or equivalent experience.
- At least 8 years of global regulatory affairs experience within Class III medical device companies with a bachelor's degree, or 5 years with a master's degree in a directly related specialty.
- Hands-on experience with Class III medical device regulatory submissions, including PMA submissions, and regulatory activities throughout the product development lifecycle.
- Strong knowledge of international medical device regulations, including APAC regulatory requirements, EU MDR, and North American regulatory pathways.
- Understanding of medical device design controls, risk management (ISO 14971), quality management systems (ISO 13485), labeling, clinical, and post-market regulatory requirements.
- Strong communication, project management, organizational, and problem-solving skills, with the ability to collaborate across global cross-functional teams.
- Proficiency with Microsoft Office and familiarity with regulatory information management platforms such as RegDesk and RIMSYS.
- Ability to travel up to 10%.
- For remote or hybrid work, internet connectivity of at least 200 Mbps download and 10 Mbps upload is required.
Nice To Haves
- Master's degree in a scientific discipline, engineering, or Regulatory Affairs.
- Regulatory Affairs Certification (RAC).
Responsibilities
- Develop and execute regulatory strategies to obtain and maintain product approvals and registrations across international markets, including APAC, EU, Canada, LATAM, and MENA.
- Prepare and manage regulatory submissions, including PMAs, PMA supplements, 510(k)s, IDE applications, CE marking applications, and international product registrations.
- Provide regulatory guidance throughout the new product development lifecycle, including design controls, manufacturing processes, and sustaining engineering activities.
- Lead end-to-end regulatory submissions, manage timelines, respond to regulatory deficiencies, and collaborate with regulatory authorities and in-country partners.
- Support post-market regulatory compliance, including complaint reporting, vigilance activities, change assessments, and maintenance of existing product approvals.
- Monitor evolving international regulatory requirements and provide guidance on product labeling, testing, clinical requirements, and market-specific compliance.
- Collaborate with Regulatory Affairs, Clinical Affairs, Quality, and Development teams to support product releases, regulatory audits, and continuous process improvements.
Benefits
- Medical, dental, and vision coverage.
- Health Savings, Health Reimbursement, Flexible Spending, and Dependent Care Accounts.
- TeleHealth options.
- 401(k) plan with company match.
- Company-paid life and AD&D insurance, with additional supplemental coverage available.
- Company-paid short- and long-term disability coverage, with buy-up options available.
- Accident and Hospital Indemnity coverage.
- Legal and identity-theft assistance.
- PTO or sick and vacation time, floating Diversity Day, and paid holidays.
- Paid parental bonding leave.
- Employee Assistance Program, including 24/7 mental health support hotline and five company-paid counseling sessions.
- Internal career growth opportunities.
- Tuition reimbursement.
- Hearing aid discount for employees and family.
- Internal social recognition platform.
- Commission- or bonus-eligible compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
