- MDN 1204 Non-active devices for wound and skin care (., wound dressings)
- MDN 1206 Non-active ophthalmologic devices (., contact lenses, contact lenses solutions)
- MDN 1208 Non-active surgical instruments
- MDN 1212 / MDA 0314 Non-active / active devices for organ preservation, IVF/ART
- MDS 1001 Devices incorporating medicinal substances
- MDS 1002/1003 Devices manufactured utilizing human/animal tissue
- MDS 1005 Sterile devices
- If you have previous experience from working at a Notified Body as a Product Specialist/Technical Documentation Assessor, that is a strong advantage.
- Successful completion of a university or a technical college degree or equivalent qualification in relevant sciences, for example medicine, pharmacy, engineering, biology, microbiology, chemistry, materials science, veterinary medicine, physiology, toxicology or physics.
- Minimum four (4) years' professional experience in the field of healthcare products or related activities, .:
- work in medical devices industry or closely related industries (. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
- work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
- work in the application of device technology and its use in health care services and with patients
- testing devices for compliance with the relevant national or international standards
- conducting performance testing, evaluation studies or clinical trials of devices
- Minimum two (2) out of these four years shall be in the design, manufacture, testing or use of the device or technology to be assessed.
- The Notified Body within Intertek is accredited to certify companies according to the EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR). Reviewing documentation, assessing products, performing quality management system audits and unannounced audits are part of the certification and the Notified Body's department.
- As a Technical Documentation Assessor in our department, you will review technical documentation from our customers within the medical device industry around the world. Review of documentation is carried out according to a specific process, including writing reports mainly in English.
- We are currently expanding our area and therefore looking for a number of Technical Documentation Assessors. Today we are a growing company eager to optimize our processes, work more efficiently and expand our knowledge and competencies.
- As a Technical Documentation Assessor, you can expect to interact, on a frequent basis, with internal and external personnel including our customers, other members of the Notified Body team and management.
- The role is permanent and not location specific since you will be able to be home based.
- Competitive salary/benefits
- Development and career opportunities around the Globe
- Working in a highly motivated team and dynamic working environment
Technical Documentation Assessor - Buckinghamshire, United Kingdom - Intertek
Description
ABOUT YOU
Intertek Medical notified Body are looking for experienced and thorough individuals, focused on delivering accurate and robust assessments, to take on the role as reviewers of technical documentation for MDD (93/42/EC) and MDR (2017/745). If you want to be part of our journey, apply today.
Required skills and experience:
ABOUT THE OPPORTUNITY
Key activities:
WHAT WE OFFER
Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and we thrive working together with precision, pace, and passion. We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.
We are an Equal Opportunity Employer who do not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies.