Sr. Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
My client is a highly desirable Medical Device design and manufacturing company in Galway, and is commutable from parts of Clare and Mayo. There’s a new vacancy for a Senior Regulatory Affairs Specialists who will be directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements. This role would suit someone with strong Regulatory or QP experience and looking for up into a role where you can really make an impact on the department.
About the role:
• Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
• Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products. Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Engages with global regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing global regulatory strategies.
• Leads regulatory filings to support submissions, license renewal and annual registrations.
• Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.
• Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes
• Mentors and coaches other employees within the department and provides leadership support to ensure strong talent development.
• Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements.
• Develops strategies for earliest possible global approvals of regulatory filings.
• Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
Personal attributes of the successful candidates:
• Recognized expert, capable of managing large projects or processes.
• Dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
• Strong coach/mentor and can provide coaching/training to other employees within the RA Department.
• Qualified Person or Bachelor’s Degree/Masters in Science, Engineering or similar.
• 7+ years of Regulatory experience in Medical Devices and/or Pharmaceuticals is essential.
For further information on this Senior Regulatory Affairs Specialist role in Galway, please contact Marchon Monroe on 0860449473 / email@example.com
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Senior Regulatory Affairs Specialist My client is a highly desirable Medical Device design and manufacturing company in Galway, and is…
Regulatory Affairs Manager My client is a Galway based medical Device manufacture with a new positions for a skilled Regulatory…
Regulatory Affairs Specialist My client is a highly esteemed Medical Device manufacturer in Galway with sites around the world! There’s…