Regulatory Affairs Specialist

Summary:

Responsibilities

· Provide direct support for site change management by providing documented regulatory assessments/ strategies, change governance, and metric reporting to optimize implementation of product / process changes and approvals for new and existing products.

· Support the global change management process through proactive engagement with key stakeholders (other impacted sites).

· Manage implementation of change requests for impact on regulatory market filings, and update and manage global registrations where applicable

· Preparation of regulatory submissions incl. 510(k), PMA supplements, Annual Reports and Registration Dossiers for International Regulatory agencies.

· Maintain compliance and accuracy of CE Technical Files aligned with site initiated device and process changes.

· Participate in and assist with external facility inspections.

· Drive communication with other surgical MTO RA affiliates, as per project requirements.

· Monitor global market regulatory changes, advise and/ or implement changes to ensure compliance.

· Support the coordination and implementation of product labelling changes from a global regulatory perspective to ensure compliance with applicable regulations.

· Involvement in the general activities within the department, including improving and implementing integrated regulatory business processes.

· Keep up to date with regulatory publications and guidance documents to stay informed about current regulatory actions that may impact owned devices.

· Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements

· Ensure continual Quality System compliance by adherence to established and evolving QS requirements.

Requirements

· Bachelor degree in Science or Engineering

· 4 years' experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment.

· Pro-active with proven ability to work under own initiative, problem solve and be a strong team player

· Ability to work on diverse project teams to provide Regulatory expertise and leadership.

· Proven track record in writing Regulatory medical device submissions

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