BSI Group

Certification Specialist - Medical Devices

BSI Group
Milton Keynes, United Kingdom
17 Sep 2019
17 Oct 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
The Opportunity

As a Certification Specialist you'll be responsible for managing the Medical Device ISO 13485 certification scheme within our Regulatory Services Team. There are 3 positions available in total. 2 within General Devices and 1 within Orthopaedic and Dental.

You will be the focal point of contact for BSI clients world-wide for certification related services and provide direct support to our Medical Device Scheme Managers for CE-marking certification schemes.

About BSI

BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.

Our Medical Device team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognised in many global markets.

As a Certification Specialist you'll have the opportunity to thrive in a highly regulated and challenging environment where your contributions are really valued.

About You

You'll be working in a customer orientated environment associated with medical devices and have a good understanding of both quality management principles and the quality management system certification processes.

Your structured approach, excellent organisation and prioritisation skills mean that you plan effectively, have an eye for detail and are committed to delivering an excellent service, on time.

An effective communicator and team player you'll be able to cope with varying scenarios whilst still being customer focused.

In addition to the above you'll also have:
  • Knowledge/awareness of Quality Management Systems such as ISO 13485 (or similar) with experience of relevant QA/QC processes or internal/external audits
  • Worked in a regulated environment such as medical devices (or other similar regulated industries)
  • Knowledge of design, development, manufacture, packaging and sterilisation of medical devices is advantageous but not a necessity
  • Strong communication skills in variety of formats e.g. customer facing, e-mail and phone
  • Sound computer skills (e.g. Windows, Excel, Word) and ability to learn BSI systems

What we offer

We offer a highly competitive starting salary and annual bonus. We are offering 27 days annual leave with the opportunity to increase this to 30 days, discounted gym memberships, private medical care (options to include you and your family), cycle to work schemes and a wide range of other flexible benefits that you can tailor to suit your lifestyle.

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