Specialist regulatory affairs and quality assurance for IVD medical devices

Full-time – Medical Device Regulatory Affairs and QA specialist (RA)

The candidate will be part of the Governance, Risk and Compliance (GRC) team which leads all the actions related to compliance and quality within the ABL group.

Job Summary

• This position will participate to gain approval of new products, new intended uses for existing products, and approval of existing products in new regions and changes to existing products.
• The products are standalone softwares and reagents.

Qualifications

• Have a minimum of 3-5-years of experience in a med-tech company or similar life-sciences organization.
• Experience (user and implementer) with ISO 13485:2016 and EN ISO 14971:2012.
• Other experience and knowledge related to quality standards used for medical devices is a plus.
• Good knowledge and understanding of new (EU) regulations (2017/745 & 2017/746).

Other

• Fluent in spoken and written English.
• Team player able to interact with multiple functional disciplines.
• Task-oriented individual with a high-level of attention detail skills.