Regulatory Affairs Specialist
CK Group is recruiting for a Regulatory Affairs Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Hull for a 6 month initial contract and has an hourly rate of £34.75 PAYE / £45.80 LTD.
The Company: Our client is a company that supports healthcare professionals in over 100 countries in an effort to improve the lives of their patients. The company takes a pioneering approach to the design of advanced medical products and services by securing wider access to their diverse technologies for more customers globally and by enabling better outcomes for patients and healthcare systems. They hold leading positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine to name a few.
Location: Hull is a port city in East Yorkshire, is named as the UK's City of Culture 2017. The city is at the eastern end of the M62 and can be easily accessed from the rest of the UK motorway network. It has good access from Lincolnshire and the south via the A15 and the Humber Bridge, and can be accessed by the A1079 from York and the North.
The Role: To provide regulatory expertise to ensure that regulatory approvals are obtained and maintained in accordance with the agreed registration programme and the needs of the business plans. Particular focus upon the new European Medical Device Regulation (MDR).
- Compile, review and approve, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications. Particular focus upon the new European Medical Device Regulation (MDR).
- Complete the requirements of the Registration Programme as agreed with the AWM and Operations departments.
- Provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
- In relation to the above, to interpret individual country legislation relevant to business.
- Liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
- Review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
- Review and approve change control impact assessments for products.
- Approve European Technical Files and regulatory despatches, where appropriate.
- Deputise for the Regulatory Affairs Managers when required.
- Ensure compliance to cGMP, cGDP, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices.
- Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
- An honors degree, in a science subject or equivalent industry experience.
- At least 5 years related experience within this type of role.
- Minimum of 3 years regulatory experience or equivalent within a regulatory compliance function.
- Medical Device experience and understanding EU Medical Device legislation is essential.
- Good interpersonal skills are essential.
For more information or to apply for this position, please contact Heather on 0191 3848905 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47053 in all correspondence.