Details:
- Salary: £35,000 - 50,000 - Annum
- Job Type: Permanent
- Job Status: Full-Time
- Salary Per: Annum
- Location: Marlborough
- Date: 1 week ago
Description:
Regulatory Affairs Specialist- £35,000-£50,000 DOE–Marlborough, SN8
The Role
Do you possess a strong understanding of medical device regulations, coupled with at least 3 years’ experience in medical device regulatory affairs and MDR? If so, we have an exciting opportunity for you.
We are a global wound care manufacturer, looking to appoint a knowledgeable and experienced Regulatory Affairs Specialist to our growing team.
You will play a crucial role in our Quality Team. Your primary responsibilities will include managing MDR, CE/CA, product registration, and all regulatory aspects of post-market surveillance. You will ensure compliance with all applicable standards, regulations, and guidance to support both pre- and post-market requirements.
If you meet the requirements and are ready to take on this challenging and rewarding role, we would love to hear from you.
Key Responsibilities:
As a member of the QA/RA team, liaise with First Water Ramsbury Ltd’s R&D and Commercial Business Development to provide regulatory input into NPI projects.
Timely preparation and submission of regulatory applications (eg: 510(k), CE Marking, Design Dossier, Product Registrations, IDE, Supplements, Annual Reports, PMA and PMA supplements)
Interface with regulatory reviewers through written and oral communications as needed and assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.
Liaise with other First Water Ramsbury Ltd departments serving as a Regulatory representative on cross-functional teams including, but not limited to, First Water Ramsbury Ltd Quality, R&D, Supply Chain and Operations and other Gentell Inc subsidiaries.
Undertake deputised duties as required.
The Company
First Water Ramsbury Limited is part of a larger group of wound care providers supplying wound adhesive dressings and solutions, manufactured for the Healthcare and Industrial markets. We have a wide-reaching footprint, with manufacturing and operations facilities in Europe, North America and Canada.
The Benefits
Company pension scheme 5% contributions.
Incapacity insurance for a 2 yr period.
Death in Service of 3 x salary.
Company sick pay scheme 4 weeks full pay followed by 4 weeks half pay plus statutory sick pay.
Enhanced maternity benefits.
The Person
A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics) and/or a significant area of expertise of Medical Devices developed through experience and a positive track record.
Minimum of 3 years of experience in medical device regulatory affairs and MDR.
Experience in clinical evaluation report writing for medical devices is essential.
Detailed knowledge of the worldwide regulations and guidance for medical devices.
Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
Understanding of Quality Management Systems - FDA QSR, ISO 13485.
Understanding of Supplier Management
Detail-oriented and excellent written and verbal communication skills