We are seeking an experienced Senior Regulatory and Quality Consultant to lead and execute strategic and operational activities for regulatory compliance and quality assurance for medical devices and in vitro diagnostics (IVDs). This role requires a deep understanding of global regulatory requirements (e.g., FDA, EU MDR/IVDR, Health Canada, etc.) and quality management systems (QMS) standards (e.g., ISO 13485, FDA 21 CFR Part 820). The successful candidate will work closely with clients, cross-functional teams, and regulatory agencies to ensure compliance and market access for innovative products.
Key Responsibilities:
Regulatory Affairs:
- Develop and execute regulatory strategies to achieve timely market access for medical devices and IVDs in global markets.
- Prepare and submit regulatory submissions, including but not limited to:
- 510(k), De Novo, and PMA for FDA.
- Technical Documentation for CE marking under MDR and IVDR.
- Health Canada licensing applications.
- Serve as the primary point of contact with regulatory authorities, responding to inquiries and managing audits or inspections.
- Provide guidance on classification, predicate selection, and regulatory pathways for novel devices and IVDs.
- Stay updated on regulatory changes and advise clients on implications for their products.
Quality Assurance:
- Develop, implement, and maintain quality management systems compliant with ISO 13485, FDA QSR, and other applicable standards.
- Conduct internal and external audits, including supplier audits, and provide recommendations for remediation and improvement.
- Oversee risk management processes in accordance with ISO 14971.
- Support clients in addressing non-conformities, CAPAs, and post-market surveillance requirements.
- Facilitate training sessions for client teams on quality standards and regulatory expectations.
Project Management:
- Lead client projects from planning to execution, ensuring deliverables are met on time and within budget.
- Collaborate with cross-functional teams, including R&D, clinical, and manufacturing teams, to align quality and regulatory objectives.
- Provide mentorship and guidance to junior consultants and team members.
Qualifications:
Education:
- Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Regulatory Affairs, Life Sciences).
- Advanced degree (MS, MBA, PhD) preferred.
Experience:
- Minimum of 7-10 years of experience in regulatory affairs and quality assurance for medical devices and/or IVDs.
- Proven track record of successful regulatory submissions (e.g., 510(k), PMA, EU MDR/IVDR Technical Documentation).
- Experience with QMS implementation and management under ISO 13485 and FDA QSR.
- In-depth knowledge of risk management (ISO 14971), software validation (if applicable), and clinical evaluation requirements.
Skills:
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Ability to work independently and manage multiple projects simultaneously.
- Proficiency in regulatory and quality tools and software.
Preferred Qualifications:
- RAC (Regulatory Affairs Certification) or ASQ (American Society for Quality) certifications.
- Experience with global markets (e.g., China, Japan, Australia).
- Familiarity with cybersecurity requirements for connected medical devices.
