Principal Regulatory Affairs Specialist
Interested in becoming part of a thriving Medical Device business that focuses on cutting edge technology and impact the lives of millions worldwide? Our client a global Medical Device manufacturer are hiring due to continued business growth. They are seeking a Senior and Principal level Regulatory Affairs professional to join them on a permanent basis.
- Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
- Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies for changes to existing products.
- Engages with regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing regulatory strategies.
- Engages with global international regulatory partners to support regulatory strategy for changes to existing products.
- Leads regulatory filings to support submissions, license renewal and annual registrations.
- 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
- Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.
- 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.
- We are looking for a qualified person to Level 8 Science or Engineering Degree/Masters. A Regulatory Affairs qualification is desirable, but not mandatory.
- Regulatory experience in Medical Devices is required.
- You are a recognized expert, capable of managing large projects or processes.
- You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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