Product Specialist for Active and Non-active Devices
Salary: Competitive
Location: Remote Role
A leading global Medical Device manufacturer is currently seeking to hire a Product Reviewer to join their growing team in Europe. You will play a key role in the company's growth strategy and success of their business.
Additionally, you will be able to make an immediate impact on their European operations with leading MedTech manufactures.
Key responsibilities of the Product Reviewer include:
- Planning and conducting product related assessment, except for clinical data according to MDR 2017/745.
- Draw up records and reports such as technical assessment report demonstrating that the relevant conformity assessment activities have been appropriately carried out
- Interactions with authorities on change related to products covered by special procedures
- Interactions with authorities on change related to products covered by special procedures
- Responsible for identifying the activities, milestones, duration and competences needed within knowledge area for the entire conformity assessment project as part of establishing the project plan
- Advise the audit team, and in particular the audit team leader, on aspects of the manufacturer's design or production processes which could be of particular relevance for the on-site audit
Key requirements of the Product Reviewer include:
- University (B.Sc.) or technical college degree in relevant studies such as medicine, pharmacy, engineering, or other relevant sciences.
- Over six years of work experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research.
- Minimum two of the six years shall be in the design, manufacture, testing or use of the device or technology to be assessed, or gained the experience as an assessor for a medical device notified body.
- Strong knowledge about the medical device standards and EU legislation
- Excellent verbal and written communication skills in English
If you are interested in the role, apply online today, call +44 203 667 8385 or email your updated CV for a confidential chat.
