Clinical Professionals Ltd

Senior Regulatory Specialist

30,000 - 40,000
27 Nov 2018
14 Feb 2019
Regulatory Affairs

Senior Regulatory Affairs Specialist
Industry: Medical Devices
Salary: 39K
Full time / Office based
Competitive salary and benefits

This Globally recognised Medical Devices Organisation specialises in manufacturing & supplying orthopaedic devices to the Healthcare sector. They now have an exciting opportunity for a Senior Regulatory Affairs Specialist to join their highly successful team based in Hertfordshire.

Developing and applying immediate knowledge and understanding of the legal frameworks, regulatory requirements, legislation, processes and procedures
Assessing regulatory intelligence to assist in the development of local, regional and global regulatory requirements
Evaluating the regulatory environment and contributing to providing internal advice, throughout the product lifecycle (e.g. concept, development, manufacturing, marketing) to ensure product compliance
Dealing with regulatory obstacles and emerging issues throughout the product lifecycle and developing solutions
Identifying requirements and potential obstacles for market access distribution (federal, provincial / territorial state, reimbursement, purchasing groups, etc.)
Assisting in the development of regulatory strategy and updates based upon regulatory changes
Evaluating proposed products for regulatory classification and jurisdiction
Determining requirements (local, national and international) and options for regulatory submission, approval pathways and compliance activities
Negotiating with regulatory authorities throughout the product lifecycle
Providing regulatory input and technical guidance on global regulatory requirements to product development teams
Assessing the acceptability of quality, preclinical and clinicals documents for submission filing to comply with applicable regulations
Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and propose plans / strategies for changes that do not require submissions
Providing knowledge and guidance on preapproval inspections, GCP inspections and clinical investigator relationships

Successful candidates will have the followings skills & experience:
Previous Regulatory Affairs experience within the Medical Devices sector
Experience of premarket surveillance, technical files and submissions
Project management, writing coordination and execution of regulatory items experience

Please note in order for your application to be successful you must hold a valid right to work document for the UK as no sponsorship is offered.

To apply for this role please send your CV through to Kully Sahota, Senior Consultant, or call 07557 047 380 / 0207 822 1710 for more information

Similar jobs

Similar jobs