Principal Regulatory Affairs Specialist
Sigmar Recruitment
Galway
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. Experience: 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 roconnor@sigmar.ie. .
1247 days ago