Please note: This role is only open to PERMANENT residents in the UK. We are unable to enter into any sponsorship arrangements.
Company Description
Implants International Ltd. is a long-established, bio-engineering company dedicated to excellence in the arthroplasty, trauma, and spinal implant sectors. All products are designed, developed and manufactured on site and our plant is ISO, FDA & CE Accredited.
We are a small but long-established progressive company at the cutting edge of our industry of manufacturing, testing and marketing orthopaedic, trauma and spinal implants. It is a challenging but interesting industry that helps transform peoples' lives in a somewhat dramatic and often life-changing manner.
We are based in Thornaby, and looking to recruit a candidate with experience in the role of Regulatory/QA Affairs in the medical device field.
The candidate must have a good understanding of working to Quality ISO 13485:2016 and FDA 21 CER 820 Standards , and be familiar with complying to MDR Standards, particularly in the field of medical devices.
The ideal candidate will have:
Experience and familiarity with MDR and FDA protocols in the medical devices field.
Experience of maintaining product Technical Files
Experience and ability to manage and optimise documentary control using software such as Adobe Pro, Word, excel etc
Be Self-motivated and keen to learn and take on challenges
- Possess good analytical skills with strong attention to detail.
- Excellent communication and organizational abilities
- Able to work independently as well as a part of a team
- Possess good interpersonal skills,
- Have excellent written and spoken language skills
- Be adaptable and flexible
- Good time-keeping and attendance
We would love to have you on board if you are up for the challenge of joining our Team as we embark on exciting, new challenges ahead.
Salary: £35,000 pa
Hours of work: 8.30 am to 4.30 pm Monday to Friday
Holidays: 30 days pa (incl stats) for year 1 rising to 33 days after 3 years
Car Parking: Free on site
Job Types: Full time
Job Types: Permanent
Job Types: Full-time, Permanent
Pay: £35,000.00 per year
Work Location: In person
