Medical Device Regulatory Affairs Consultant
Contract – St Paul, MN
Talencio has been engaged to lead a search for a Medical Device Regulatory Affairs Consultant for a 40 hours/week contract assignment lasting approximately 8 – 12 months. Talencio’s client is a St. Paul, MN based medical device company. They are aiming to build a team of people to help with the remediation efforts required to update their technical files and design dossiers for their Surgical products (Europe Class I, Class Is, Class IIa) made in North America and sold in Europe (EU) in order to comply with the new EU Medical Device Regulation (EU MDR).
The Medical Device Regulatory Affairs Consultant will be primarily responsible for updating technical files and design dossiers to meet the new EU MDR requirements. The person in this role will need to have an in-depth knowledge of both the EU Medical Device Directive (EU MDD) and EU MDR. They will be responsible for reviewing a technical file, identifying gaps needed to transition from EU MDD to EU MDR, and then managing the applicable documentation updates. They will also be responsible for developing and/or updating EU technical documentation templates as needed. This person will need to be “hands-on” to manage and execute documentation updates.
- Review and assessment of changes to product design, manufacturing, and/or labeling.
- Review of product promotional materials.
- Review of legal agreements (e.g. suppliers or OEM customers).
- Execution of other MDR or remediation activities, as needed.
- Bachelor’s degree within a scientific or technical discipline.
- 3 years of Regulatory Affairs experience specifically with design control, design dossiers or technical files in the medical device industry.
- EU MDD experience and EU technical documentation writing proficiency.
- Excellent verbal and written communication skills.
- 5+ years of Regulatory Affairs experience specifically within the medical device industry.
- RAC Credential.
- Experience with EU Class I, Class Is and Class IIa devices.
- EU MDR experience.