Regulatory Associate

3 weeks ago

Yeadon, United Kingdom Xiros Ltd Full time

We are looking for a Science or Engineering graduate to join our small Regulatory team based in Yeadon, Leeds as a Regulatory Affairs Associate to ensure that our têxtile-based, orthopaedic, implantable medical devices can continue to be sold throughout the world.

**The role**:

- Support with generating Technical Files and Device Master Records for newly registered devices.
- Perform Risk Management file reviews and updates for approved devices.
- Perform reviews of documents for other departments in the company.
- Support with day to day regulatory and administrative tasks, i.e., maintenance of Medboard, MHRA site, BSOL, standard reviews etc.,

**Essential Requirements**:

- You must be a self-starter, proactive, driven and well organised with good administrative skills.

**Desirable Requirements**:

- Previous experience in a Regulatory or Quality Affairs role within medical devices would be advantageous.
- Experience in supporting distributor approval in a medical device company would also be beneficial.
- Experience in writing and reviewing Technical Files.
- Experience of new product registration in the USA (510k) and EU (CE marking).

Excellent range of core and flexible benefits including non-contributory S.I.P.P; cash plan; opportunity for private medical insurance, gym membership, MCard; enhanced holiday allowance; subsidised lunches; free drinks and fruit; wellness programme; free and subsidised sports and social events; company parties; flexi-time; opportunity to work on site three days per week and remotely two days per week; ongoing training and development.

No agencies please.

Pay: £33,250.00-£38,000.00 per year

**Benefits**:

- Additional leave
- Bereavement leave
- Company events
- Company pension
- Cycle to work scheme
- Discounted or free food
- Free flu jabs
- Free parking
- Gym membership
- Health & wellbeing programme
- Life insurance
- Paid volunteer time
- Private medical insurance
- Sabbatical
- Sick pay

Schedule:

- Flexitime
- Monday to Friday

Ability to commute/relocate:

- Yeadon, LS19 7UE: reliably commute or plan to relocate before starting work (required)

Application question(s):

- What experience do you have of undertaking regulatory submissions for implantable medical devices?
- What is your highest level qualification?
- Are you authorised to work indefinitely in the United Kingdom?

Work Location: Hybrid remote in Yeadon, LS19 7UE

Application deadline: 24/11/2023

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