Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
Job Title: Regulatory Affairs Manager
Job Location: Gloucester UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level:
Employment Type: Permanent Full:time (Monday : Friday Hybrid Options Available)
Salary: Competitive DOE
Overview
Hawk3 Talent Solutions is seeking a Regulatory Affairs Manager to join a manufacturing organization located in Gloucester.
The successful candidate will be responsible for ensuring business compliance with relevant legislation and quality standards to support the companys overarching objectives of delivering cost:effective high:quality products while providing exemplary customer service. Key responsibilities include:
: Maintaining current knowledge of both domestic and international regulatory requirements and effectively communicating this information to management and project teams.
: Supporting the processes necessary to ensure that the Quality Management System is upheld in alignment with applicable regulatory and statutory requirements including ISOCFR 820 MDD 93/42/EEC Regulation (EU) 2017/745 and ISO 14971.
: Issuing advisory notices as necessary in accordance with the MDD MDR and FDA regulatory requirements (21 CFR 803).
: Developing preparing and maintaining high:quality technical files design dossiers and any other required documentation for regulatory submissions and approvals.
Qualifications
: Proven experience in regulatory affairs particularly in a managerial capacity.
: Essential experience with medical devices.
: Completion of Lead Auditor training.
: Strongly desirable experience with MDR
Benefits
25 days holidays plus bank holidays
Pension : Nest
Single Vitality Healthcare : upon successful completion of the probationary period
Perkbox
Hawk 3 Talent Solutions are operating as an employment agency on behalf of its client.
please follow the application process for the site this job is advertised on or to By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. To view our full Privacy Policy our website.
Hawk 3 Talent Solutions are committed to the selection recruitment and development of the best people basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually due to high volumes this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future
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Employment Type
Full Time
