Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to be based in the North West of England.
Responsibilities:
- Direct and prepare regulatory submissions as required for global approvals for IVDs, including preparation of reports and interaction with regulatory officials.
- Review product labelling and promotional literature for regulatory compliance.
- Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
- Liaise with regulatory agencies for enquiries and issues.
- Review R&D protocols and technical reports and other company documents for use in regulatory submissions and in response to questions from regulatory authorities.
- Oversee and direct the preparation of regulatory documentation for country specific registrations.
- Develop regulatory SOPs relevant for registration of IVD products or other regulatory aspects.
Person specification:
- Extensive experience in the medical device industry, preferably with IVD experience and extensive regulatory affairs experience.
- Experience in the preparation and submission of 510K, PMAs, IND, CE Design Dossiers, CE Technical Files.
- Possess a working knowledge of MDD and IVDD, applicable ISO standards.
- Ability to work as part of a team.
- Excellent influencing and negotiating skills.
- Excellent verbal and written communication skills.
How to apply:
For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera on 01438 870024 or email a copy of your CV to mpattni@ckregulatory.com. Please quote reference CL22924 in all correspondence.
