The Regulatory Associate role is critical in ensuring that the company’s medical devices meet all necessary regulatory and quality standards while supporting the development and commercialization of hip resurfacing and total hip arthroplasty implants. Reporting to the VP of Quality Assurance and Regulatory Affairs, this position is responsible for regulatory compliance, regulatory strategy, and engagement with regulatory bodies globally. This position offers a unique opportunity to impact the development and compliance of innovative orthopaedic devices, with a focus on regulatory excellence and quality assurance leadership.
The primary purpose of the position:
Reporting to the VP QARA, the Regulatory Associate is to oversee and execute all aspects of:
Regulatory Complianc
- Ensure compliance with regulations from FDA, ISO (e.g., ISO 13485), and other international agencies.
- Develop and oversee internal systems to meet regulatory requirements.
Regulatory Strategy Development
- Create regulatory strategies for JointMedica’s products in preparation for market entry.
- Align strategies with commercial goals, prioritizing key regulatory clearances identified in the Global Regulatory plan.
Submission Preparation
- Project management of new product introductions to various markets.
- Align Technical Files and Design Dossiers in preparation for submission to regulatory authorities.
- Inform the group’s bench testing focus and cadence based on regulatory requirements.
- Assist JointMedica’s Regulatory teams (internal and external) in the creation of materials to support, 510(k), PMA, IDEs, and other regulatory applications.
Regulatory Intelligence & Liaison
- Stay updated on regulatory trends and advise on the implications of any changes for product development and distribution.
- Serve as the main contact for regulatory agencies, managing communications and audits.
Risk Management & Compliance Audits
- Contribute to risk management programs for identifying and mitigating risks to ensure regulatory compliance.
- Participate in compliance audits to assess adherence to regulations and standards.
Post-Market Surveillance & Clinical Integration
- Support post-market clinical surveillance efforts, incorporating findings into product improvements.
- Generate Clinical Evaluation Reports to support the JointMedica product portfolio.
- Assist in updating surgical techniques and surgeon training based on clinical outcomes.
Design and Development Input
- Utilize clinical insights to guide the design and refinement of implants and instruments.
- Maintain design history files (DHFs) and ensure adherence to design control protocols.
REQUIRED SKILLS AND QUALIFICATIONS.
- Bachelor’s degree in biomedical engineering, life sciences, a related field, or relevant industry-specific experience.
- Regulatory Affairs Certification (RAC) desirable.
- Strong knowledge of FDA regulations (21 CFR 820), ISO, and international medical device standards.
- Proficient in regulatory submissions, including 510(k), PMA, and Technical Files.
- Analytical problem-solving and decision-making capabilities.
- Proficiency in database management and quality assurance tools.
- Strong communication skills for interaction with internal teams and regulatory bodies.
- Understanding of medical device trends, competitive landscape, and emerging technologies.
- Experience with hip resurfacing or total hip arthroplasty products is an advantage.
- Demonstrated ability to manage regulatory processes from development through post-market stages.
- Track record of achieving timely regulatory clearances for medical devices.
- Experience working with external regulatory consultants and in-country experts to streamline global market entry.
Job Types: Full-time, Permanent
Additional pay:
Benefits:
- Additional leave
- Company pension
- On-site parking
Schedule:
Work Location: In perso
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