Senior Regulatory Affairs Manager

Biocare Medical; Martinez (CA); On-site; USD 100,000 - 170,000; Full time

Job summary

A leading company in medical diagnostics is seeking a Senior Regulatory Affairs Manager to oversee regulatory strategy and compliance for their IVD product portfolio. This role involves mentoring a team, ensuring compliance with global regulations, and collaborating across departments to maintain high standards. Ideal candidates will have significant experience in the industry and a proven track record of compliance excellence.

Benefits

Company Sponsored Health Insurance

Company Sponsored Life Insurance

Retirement plan - 401(k)

Paid Time Off (PTO)

Paid Holidays

Qualifications

• Minimum 8 to 10 years working in regulated medical device/IVD or related industry.
• 4+ years of management experience required.
• Hands-on experience in the IVD field.

Responsibilities

• Lead, mentor, and manage the Regulatory Affairs (RA) team.
• Develop and implement global regulatory strategies for IVD products.
• Act as the primary RA liaison for product submissions.

Skills

Analytical skills

Problem solving

Communication skills

Education

Bachelor's degree or equivalent experience

Tools

eQMS (MasterControl, AssurX, Veeva Vault QMS)

Microsoft Office Suite

Job description

Join to apply for the Senior Regulatory Affairs Manager role at Biocare Medical

1 week ago Be among the first 25 applicants

Join to apply for the Senior Regulatory Affairs Manager role at Biocare Medical

Get AI-powered advice on this job and more exclusive features.

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.

The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.

Summary

The Senior Manager, Regulatory Affairs is responsible for leading and mentoring Biocare Medical’s Regulatory Affairs team, with direct oversight of global regulatory strategy, submissions, and compliance activities. This role focuses on obtaining and maintaining product registrations in key markets including the EU (IVDR), LATAM, Asia, and MDSAP-participating countries, specifically for Biocare’s IVD product portfolio, including antibody-based diagnostics. The Senior Manager ensures the development and timely submission of compliant technical documentation, collaborates cross-functionally with R&D and Quality teams, and drives alignment with global regulatory requirements and internal quality standards. This position also supports the implementation and maintenance of an eQMS, and plays a critical role in fostering regulatory excellence, audit readiness, and continuous improvement across the organization.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead, mentor, and manage the Regulatory Affairs (RA) team, including performance reviews, workload planning, and professional development.
• Develop and implement global regulatory strategies for new and existing IVD products (Class A to D/Class I to III), including antibodies and diagnostic systems, in key markets (EU, LATAM, Asia, MDSAP-participating countries).
• Act as the primary RA liaison for product submissions and regulatory strategy across LATAM, the EU (IVDR), MDSAP-participating countries, and Asia.
• Oversee preparation, submission, and maintenance of regulatory documentation, including CE Mark, Health Canada, ANVISA, NMPA, MFDS, and other country-specific filings.
• Write and manage compliant technical documentation (LATAM, the EU (IVDR), MDSAP-participating countries, and Asia) and ensure timely internal review and approval.
• Collaborate closely with R&D to embed regulatory requirements throughout the product design and development lifecycle.
• Provide strategic regulatory input and serve as the company representative in interactions with regulatory agencies and notified bodies.
• Review and approve technical file deliverables (e.g., validation protocols, V&V reports, PMS reports, literature reviews) to ensure compliance with IVDR and other global requirements.
• Ensure timely development and delivery of high-quality regulatory documents, including GSPRs, gap assessments, risk management documentation, and post-marketing surveillance reports.
• Deliver internal training on global regulatory requirements, with a strong emphasis on IVDR.
• Leverage eQMS experience to support implementation and ensure ongoing regulatory compliance, system integrity, and alignment with global quality standards.
• Develop and maintain regulatory SOPs, guidance documents, and templates; lead and deliver company-wide and RA team-specific compliance and regulatory training.
• Support the compliance and CAPA team.
• Identify and implement process improvements to enhance department efficiency, documentation quality, and regulatory compliance.
• Track and report on the status of regulatory deliverables to senior management; participate in management reviews.
• Support external audits and inspections by coordinating with notified bodies and internal teams.
• Update existing legacy technical files to ensure compliance with IVDR requirements, including format, content, and risk documentation.
• Maintain up-to-date knowledge of global regulatory requirements, industry trends, and evolving standards.
• Promote a culture of regulatory excellence and continuous improvement across the organization.
• Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings
• Oversee coordination with external regulatory consultants and local agents for international submissions; lead planning and management of the regulatory affairs budget, ensuring alignment with project priorities and organizational goals.
• Perform other duties as assigned by Management.
  
  

Competencies

• Bachelor’s degree or equivalent experience and a minimum of 8 to 10 years working in regulated medical device/IVD or related industry.
• Minimum 4+ years of management experience required.
• Hands on senior leader with significant experience of working within the IVD field.
• Expert knowledge of the compliance requirements of IVD Regulation 2017/746, NMPA, MFDS, AMDD, etc.
• Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP
• Demonstrates strong analytical, critical thinking, problem solving and investigative skills.
• Excellent interpersonal skills and the ability to work collaboratively with the wider team.
• Excellent organizational skills, attention to detail and an ability to work to tight timelines under minimum supervision.
• Excellent oral and written communication skills.
• Experience with eQMS (MasterControl, AssurX, Veeva Vault QMS).
• Strong computer and internet research literacy with proficiency using Microsoft tools (Word, Excel, PowerPoint, Outlook)
  
  

Expected Location & Hours of Work

• Onsite - Pacheco, CA
• 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.
  
  

Compensation Range

• $100,000 - $170,000 annually
  
  

Full-Time Positions Offer

• Company Sponsored Health Insurance - medical, dental, vision,
• Company Sponsored Life Insurance
• Voluntary Benefits
• Retirement plan - 401(k)
• PTO
• Paid Holidays
  
  

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

All inquiries strictly confidential.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

Referrals increase your chances of interviewing at Biocare Medical by 2x

Get notified about new Senior Manager Regulatory Affairs jobs in Pacheco, CA.

Emeryville, CA $180,000.00-$205,000.00 4 days ago

Associate Director of Regulatory Affairs

Associate Director Regulatory Affairs – APAC - Diabetes Care

Alameda, CA $146,700.00-$293,300.00 4 months ago

San Francisco, CA $182,000.00-$227,100.00 1 day ago

Alameda, CA $167,500.00-$237,500.00 3 weeks ago

Director Life Sciences Regulatory Affairs and Labeling

Regulatory Affairs Manager – Canada & Latin America – Diabetes Care (on-site)

Alameda, CA $112,000.00-$224,000.00 1 week ago

Pacheco, CA $100,000.00-$140,000.00 1 week ago

Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)

Regulatory Affairs Manager – APAC - Diabetes Care (on-site)

Senior Manager/Associate Director Clinical Quality Assurance Auditor

San Rafael, CA $143,600.00-$215,400.00 2 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.