Our client is a long established Healthcare Group operating within the medical device manufacturing sector. They manufacture a variety of products across the healthcare market and have an established R&D focus on innovative research and development products for the Group. Due to continued growth there is a requirement for a Regulatory Affairs Manager to join this global business.
Reporting to the UK Head, the Regulatory Affairs Manager will be responsible for providing Regulatory direction and guidance to the UK businesses.
The Regulatory Affairs Manager role is key to the success of the UK businesses regulatory and quality strategy, ensuring the development of regulatory strategies.
The Regulatory Manager will establish systems for registration to approve, develop for medical device products across the company
Refine, and execute regulatory strategies to support both individual and collective business goals. Maintain up-to-date knowledge on both domestic and International Regulatory requirements Defining and managing regulatory risk management activities
The Regulatory Affairs Manager will provide input and direction into new product development
Represent the UK QARA team on matters of regulatory compliance, providing guidance and ensuring compliance across medical device products
Provide technical documentation supporting regulatory registration in assigned countries of strategic plan
The Regulatory Affairs Manager (Medical Devices) will develop, prepare, and have ready for submission, high quality technical files, design dossiers and other necessary applications for regulatory approval.
With the Quality Manager, represent the UK Businesses at all external agency & customer inspections.
In conjunction with the UK Head execute aspects for any Field Safety Corrective Actions (FSCA) in a timely, thorough, and transparent manner.
As Person Responsible for Regulatory Compliance (PRRC) for the UK Businesses, review requested Quality Management System (QMS) documentation creations, revisions & obsoletion.
Review and approve labelling, product and process changes, product documentation as it pertains to regulatory filings and clinical evidence
Deliver Internal regulatory training for departments.
The Regulatory Affairs Manager will develop and implement a system for embedding QARA culture through the UK Businesses.
In association with the Quality Manager, upon receipt review and release all new products both internal and commercial
Support both the Internal and Supplier audit schedule, conducting Inspections when assigned. Contribute to budget preparations in conjunction with UK Head
Ensure that all assigned budgets are monitored and delivered.
Provide reports on agreed frequency on all matters associated with regulatory compliance to the UKSKILLS
Track record in a in a regulatory role
Medical device environment
Medical Device or IVD environment working to ISO Standards and FDA CFR in a continuous improvement
Ideally educated to degree level or equivalent work experience
Understanding of ISO 13485, 14971, EN980, ISO11135, MDD 93/42/EEC AND MDR 2017/45
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