OUR COMPANY

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry instrumentation, and the full range of reagents for IHC lab testing. Biocare specializes in high quality IHC, ISH, and FISH slide staining through its brand-new automated instrument, NeoPATH Pro™, and offers best-in-class simultaneous Multiplex IHC solutions.
The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, biotechnology companies as well as academic, government, military, and 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 with a global distribution network.

SUMMARY

The Regulatory Affairs Specialist III is responsible for managing product compliance activities and ensuring the company’s adherence to applicable global regulatory requirements. This role supports regulatory submissions for product marketing across key international markets, including the EU (IVDR), LATAM, Asia, and MDSAP countries. The Manager analyzes evolving regulations to assess their impact on company operations, facilitates necessary process or policy updates, and collaborates cross-functionally to integrate regulatory requirements into product development and commercialization. Additionally, this position oversees maintenance of regulatory documentation, supports post-market activities, and contributes to internal training and continuous improvement efforts within the Regulatory Affairs team.

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

• Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets including the EU (IVDR), LATAM, Asia, and MDSAP-participating countries.
• Compile, review, and maintain regulatory technical documentation (e.g., technical files, GSPRs, CERs) to ensure compliance with IVDR and country-specific requirements.
• Partner with R&D, Quality, and Commercial teams to integrate regulatory requirements into product development, design control, labeling, and change control processes
• Ensure company-wide compliance with cGMP and established procedures by collaborating with Quality Systems on adherence to GMP/QSR and ISO 13485/MDSAP standards.
• Perform product risk assessments and support evaluation of complaints and non-conformances; assist with investigation and documentation.
• Manage and support recall, Medical Device Reporting (MDR), advisory notices, and related post-market regulatory reporting.
• Provide strategic regulatory guidance on submission planning, global compliance strategies, and risk classification to internal teams as well as literature research.
• Research and interpret global regulations to assess impact and recommend actionable compliance strategies.
• Manage product registration, listing, and licensing activities, including renewal of business licenses in global markets.
• Develop and maintain regulatory SOPs, guidelines, templates, and training content; deliver RA and company-wide regulatory compliance training.
• Review and approve product labeling, IFUs, user manuals, SDSs, and promotional content for regulatory compliance.
• Monitor complaint handling systems and support CAPA management to ensure effective resolution and prevention of recurrence.
• Track changes in global regulatory requirements and perform gap analyses to ensure continued compliance and proactive remediation.
• Generate and manage import/export documentation and facilitate customs clearance for product distribution.
• Lead or support global Post-Market Surveillance (PMS) activities including complaint trend analysis, vigilance reporting, and preparation of PMS documentation in accordance with IVDR.
• Develop and execute Post-Market Performance Follow-up (PMPF) plans to gather performance data, literature, and user feedback for integration into CERs and risk management.
• Contribute to departmental continuous improvement initiatives to enhance process efficiency, regulatory compliance, and documentation quality.
• Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings
• Assess the regulatory impact of product and process changes and contribute to the change control process to ensure timely and compliant implementation.
• Coordinate with external regulatory consultants or local agents for international submissions; support budgeting or planning activities for regulatory projects
• Other duties as assigned by Management.