Principal Regulatory Affairs Specialist | 18-month contract | Galway.
Our client, a Medical Device manufacturer is looking for a Principal Regulatory Affairs Specialist to join their team on an 18-month contract.
You will within this role support regulatory requirements for activities within manufacturing & sustain products already on the market.
The role will involve working with regulatory bodies (FDA & EU bodies) but also with colleagues throughout the globe.
You will within this role:
- Identify and develop best practices within the Regulatory Affairs Department including continuous development initiatives
- Develop strategies for earliest possible global approvals of regulatory filings
- Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed
- Keep up to date with regulatory procedures and changes. Develop internal procedure to ensure continuous compliance with all regulatory requirements
- Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes
- Lead regulatory filings to support submissions, license renewal and annual registrations.
- Influences clinical evidence strategy to support labeling content, marketing claims and regulatory compliance.
- Mentor and coaches’ other employees within the department and provide leadership support to ensure strong talent development
- Engage with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products
- Work with engineers and technical experts to develop regulatory strategies and resolve questions from regulatory agencies
- Directs and influences the preparation of documentation to support high quality regulatory submission dossiers
- Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering, or related discipline.
- Minimum of 6 year’s relevant experience in Medical Devices and or Pharmaceuticals.
- Capable of managing large projects or processes.
- You are a dynamic team player and can work effectively and pro-actively individually and in teams.
If you are interested in this role please apply with an updated CV to Rebecca O'Connor at email@example.com
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