Due to continued companywide growth, we are looking for an enthusiastic Regulatory Affairs Senior Associate to join our team.
GBUK Group of award-winning specialist companies are experts in the provision of enteral feeding, critical care and patient handling products and technologies. Within the Group, GBUK Enteral is the UK’s leading supplier of enteral feeding tubes, syringes, and gastronomy devices; GBUK Healthcare offers medical, surgical and critical care devices and GBUK Banana provides a comprehensive range of innovative safety-centred patient moving and handling systems. We supply the every NHS in the UK as well as export to over 40 countries worldwide.
Full driving licence and your own vehicle is essential for this role as there are no public transport links to our site on the outskirts of Selby, North Yorkshire.
You will be responsible for Responsible for technical dossier generation for submission; maintenance of regulatory systems; registrations and certifications; as well as assisting with any administration activities or product queries as required. You will also be responsible for regulatory input and considerations with regards to new products.
Duties will include:
- Preparation, creation, submission and maintenance of regulatory documentation in compliance with EU MDR, for submission to the Notified Body and Approved Body as applicable.
- Aid and assist with the preparation, creation, submission and maintenance of regulatory documentation in compliance with US FDA and rest of world legislation as applicable.
- Liaise with cross functional teams and senior management on regulatory projects and any new product development projects as required, to ensure compliance and timely creation, update and/or maintenance of technical documentation, ensuring deadlines are met.
- Assist in the preparation for annual QMS audits and supporting in regular internal and external audits
- Assist in ensuring compliance of product packaging, labelling and delivery documentation according to the relevant standards.
- Regulatory input into New Product Development Projects and the creation and submission of dossiers for approval of new products.
- Working with Quality Affairs for vigilance, complaints, and post market surveillance activities.
- Aid in the maintenance of regulatory databases and listings to ensure compliance, such as MHRA, FDA FURLS, GUDID.
- Raise and / or complete actions as part of the change control process
- Perform research for US market registration of devices, such as applicable FDA product codes, creation of 510k’s as necessary, and collaboration with consults.
- Assisting with any administration activities; change notification or other reasonable tasks as may be required
- Degree or equivalent certification in science related, medical, or engineering discipline.
- Regulatory experience within the medical devices sector (ideally 3 or more years experience)
- Working knowledge of the MDR, ISO 13485 and related ISO standards.
- Experience in the compilation and review of Class I, IIa, IIb and III EU technical documentation for CE marking
- Experience in the compilation and review of 510ks.
- Have the ability to assess all necessary and specific medical device regulatory obligations and to be able to advise staff and customers accordingly.
- Experience of assisting with/conducting/managing Internal & External audits
- Experience of sterilization processes
- Understanding of GS1 compliance
- Project Management experience
- Experience with Clinical Evaluation compilation to current MEDDEV guidance and Risk Management implementation to medical device standard ISO 14971.
- Experience in the compilation and review of Class III EU technical documentation for CE marking
- Management and maintenance of various regulatory databases
Key Skills and Competencies:
- Full Driving licence and own vehicle (essential as no public transport to our site)
- Problem solver
- Able to project manage multiple tasks
- Able to understand technical drawings and the manufacturing processes
- Capable of working in a team and independently
- Good communication skills
- Organised and detailed working style
- High level of computer literacy
In return we provide full training for the role and ongoing support along with a full benefits package including:
- 25 days holiday plus Bank Holidays
- Company Performance Bonus potential
- Health Cash Plan (on completion of Probation)
- Wellness programmes
- Company Events
- Company Pension
- Cycle to Work Scheme
- Referral Scheme
- Discounts in conjunction with linked companies
- Ability to purchase Additional leave
- Free parking
- Company sick pay
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
Job Types: Full-time, Permanent
Salary: £35,000.00-£44,000.00 per year
- Additional leave
- Company events
- Company pension
- Cycle to work scheme
- Free flu jabs
- Free parking
- Health & wellbeing programme
- On-site parking
- Referral programme
- Sick pay
- Store discount
- Work from home
- Day shift
- Monday to Friday
- Regulatory Affairs: 3 years (preferred)
- United Kingdom (preferred)
Ability to Commute:
Work Location: In person