Regulatory Affairs Manager

The Regulatory Manager will be responsible for supporting a varied team of managers and employees in developing and implementing regulatory strategies for New Product Development and Business Operations.

Operating remotely, you will be reviewing and interpreting regulations and guidance documents to develop the regulatory strategy to support project teams in terms of the regulatory submission pathway, predicate device selection, submission requirements, timing, and risks.

The role will lead the interactions with US FDA, EU NB/CA and other International regulatory authorities to define submission content, expedite pending applications, and resolve regulatory matters. You will be responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. Working with the Quality Manager, they will jointly lead on any certification audits.

The Regulatory Manager shall also lead the risk management activities as they pertain to the medical device and Current Health platform and be involved with other risk management, i.e., information security, business continuity, as required.

Key Duties & Responsibilities

• Supports high-level strategy and direction for regulatory submissions in all territories.
• Leads regulatory submissions for all territories.
• Leads on ensuring technical documentation is up-to-date and ready for review
• Main point of contact for regulatory discussions with product and engineering teams as it applies to new products and changes made to product, including but not limited to third-party integrations.
• Actively works with product and engineering teams to ensure regulatory requirements are met during the design and development process.
• Regulatory Review and sign off of technical reports, software changes, engineering changes
• Ensures all regulatory registrations are updated as required by their respective jurisdictions.
• Promotes regulatory awareness through regular training sessions across various teams.
• Primary review of complaints, critical incidents, corrective and preventive actions for any potential reporting requirements in accordance with relevant regulatory requirements.
• Leads risk management activities for the lifecycle of the product.
• Leads, with the Clinical team, the clinical evaluation process with respect to new/updated products to ensure compliance with applicable clinical requirements
• Leads post-market surveillance activities across the company and ensures requirements are fulfilled.
• Leads regulatory reporting activities, including MDR (FDA) and EU Vigilance.
• Reviews updated regulatory standards and guidance documents and prepares gap analyses, as required.
• Participates in all meetings with regulatory authorities.
• Final review and sign off on all regulatory documents prior to submissions to regulatory authorities.
• Perform or facilitate audits to ensure compliance (working with QA)
• Leading/participating in other compliance projects as agreed i.e. Clinical Command Center certification

Requirements

• Past experience of working in a start-up culture is preferred
• Proven experience of managing Regulatory Affairs in the Medical Device Industry with ownership of a regulatory submissions including 510(k)s, De Novos, EU submission and other territories
• Strong experience in Regulatory Affairs with demonstrated experience in the full range of submissions and in dealing with local and international regulatory agencies including the FDA
• Recent experience with complex electronic, electro-mechanical and a software as a medical device (SaMD/MDSW)
• Strong and practical knowledge of ISO 13485, FDA CFR 820, MDSAP, MDD and MDR as well as emerging standards and regulations.
• Expert in ISO 14971 risk management and able to lead on all product related risk activities
• Strong and practical knowledge of product standards, including IEC 62304
• ISO 13485 internal/lead auditor
• A BSC degree or equivalent in a Life Sciences field would be ideal
• Experience of ISO 27001 standard in a health/medical software company

Benefits

• Pension Plans
• Work From Home
• Employee Assistance Programme - Counseling
• Life Assurance
• Leave Package
• Training & Development

Tags