R & D Associate

GBUK Group is a market leading provider of Enteral Feeding, Critical Care, Vascular Access and Patient Handling medical devices. A Top 20 supplier to the NHS, with 145 staff and annual sales of £75m. GBUK has delivered 20% compound annual growth over the last 10 years and has been Private Equity backed since 2015.

As one of the R & D Associates you will be responsible for R & D activities related to the development & launch of new medical device innovations as well as supporting the compliance of GBUK’s existing medical device portfolio. You will support the business in design history, product and production history validation and verification and technical transfer of medical devices as well as be responsible for generation and maintenance of technical documentation to ensure compliance to all current Medical Device Regulations and ISO 13485 requirements.

**MAIN RESPONSIBILITIES**:

- To provide accurate and current Research & Development input to support with the development and compliance of medical devices launched and marketed by GBUK.
- Responsible for generation of documentation in the areas of design history, product and production validation and verification, usability and technical transfer.
- Responsible for working with external partners, such as laboratories, to run studies, ensuring the studies are planned correctly and delivered to agreed timings.
- Responsible for working as part of a cross functional project team, in partnership with the New Product Development team to deliver new medical device innovations and delivering changes to the existing portfolio of medical devices marketed by GBUK.
- Responsible for assisting with the generation and maintenance of SOPs and WIs related to R&D activities.
- Responsible for ensuring documentation is generated for regulatory technical dossiers to agreed timelines and to a good standard.
- Conducting R&D meetings to ensure projects and R&D actions are progressing.
- Participating in regulatory/quality system audits (internal and external) where required.
- Provide input in to change control process, impact assessments and actions required as a result of the change.

**ESSENTIAL KNOWLEDGE AND QUALIFICATIONS**:

- Degree or equivalent certification in science related, medical, or engineering discipline.
- R&D experience within the medical devices sector (ideally 2 or more years’ experience)
- Have the ability to assess all necessary and specific medical device regulatory obligations and to be able to advise staff accordingly.
- Comprehensive understanding of the MDR, IVDR and medical device ISO standards, including but not limited to 13485, 14971, 10993 and 62366.
- Experience of working in a cross-function project team.

**REQUIRED SKILLS**:

- Capable of working in a team and independently.
- Problem Solver
- Able to project manage multiple tasks
- Able to understand technical drawings
- Understanding of manufacturing processes
- Good communication skills
- Organised working style with an eye for detail
- High level of computer literacy

**Equality**:
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**: £28,000.00-£35,000.00 per year

**Benefits**:

- 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
- Work from home

Schedule:

- Monday to Friday

COVID-19 considerations:
The Company follows Covid-safe working practices and preserves the health and wellbeing of staff as far as possible.

**Education**:

- Bachelor's (preferred)

Licence/Certification:

- Driving Licence (preferred)

Work authorisation:

- United Kingdom (preferred)

Work Location: Hybrid remote in Selby

Reference ID: GBUK/RD2