REGULATORY AFFAIRS MANAGER - MEDICAL DEVICES
A leading UK-based manufacturer and supplier of world-class medical devices into the healthcare industry. They are currently experiencing a huge demand for their range of sterile products including gloves, masks, gowns and visors and are investing heavily in their UK manufacturing facilities to meet demand. Established over 30 years ago this UK manufacturer are financially secure and well positioned to continually deliver innovative products and solutions that protect our key workers in the Health Care industry so that these professionals have what they need to achieve the best clinical, patient and financial outcomes.
Desired Skills and Experience
Degree educated within a relevant field or equivalent experience
Experienced regulatory professional with working knowledge of the MDD / MDR
Experience of working with Class 1 and Class 2a (sterile) Medical devices
Experience of working in a manufacturing environment
Experience in dealing with MHRA and FDA for approvals
Knowledge of ISO13485
Knowledge of standards such as ISO9001, ISO14001 & ISO45001 would be advantageous
Experience of working with European and International Standards
Excellent IT skills and knowledge of Microsoft packages
Excellent interpersonal skills
Methodical with great attention to detail
Excellent problem-solving and decision-making skills
Excellent verbal and written communication skills
Good team working skills
Ability to work well under pressure and to tight deadlines
Responsibility for all medical devices coming out of our UK manufacturing sites as well as products which are sourced.
Maintaining current compliance of all medical devices
Ensuring all product types are listed on the MHRA website
Primary contact for Certification Bodies (BSI, Intertek, TUV, SGS etc) for product certification
Primary contact for test laboratories to arrange the relevant testing.
Communicating with Senior Management on all regulatory issues relating to the Medical Devices
Validating and approving suppliers
Responsible for collating all data for technical files including ensuring clinical evaluations are processed, risk assessments completed as well as all other items.
Collating data for the management review for ISO13485
Involvement in customer complaints relating to non-conforming product
Working closely with Production to ensure product is compliant
Enabler for change and dissemination of good practice
up to £45,000k with benefits and long term career progression
Manchester/Warrington or Dumfries
There are no specialist Health & Safety issues related to this role.
Permanent (unless otherwise stated in the job title above).
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