Offer summary

Qualifications:

Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related field., 3-5 years of regulatory experience in Medical Devices, Biotech, or Pharma., Experience with EU MDR technical documentation submissions for Class II and III devices., Basic proficiency in French is a plus, but not required..

Key responsibilities:

Lead MDR remediation efforts and guide project teams in identifying requirements and drafting technical documentation.

Collaborate with Notified Bodies to address queries and facilitate certification processes.

Provide EU regulatory requirements and guidance to project teams for EU MDR compliance.

Prepare and submit EU MDR technical documentation for various classes of medical devices to support CE marking and commercial release.

Job description

SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Regulatory Affairs Specialist to join our client's Medical Device Manufacturing Team. *Medical Device expereince required. This is a fully remote position!

*W2 contract; Speaks French (not required to be fully fluent)

MUST HAVES:

Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field.
Minimum of 3-5 years regulatory experience in a regulated industry such as Medical Devices, Biotech or Pharma
Experience in the preparation and submission of EU MDR technical documentation submissions, including EU Class II and III devices.
Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to MDR project teams.
Speaks French (not required to be fully fluent)

JOB RESPONSIBILITIES:

MDR remediation
Guiding project teams through identification of requirements/standards and drafting of technical documentation
Working with Notified Bodies through query and response to certification
IEC 60601 / IE 62304
Independently provide EU regulatory requirements and guidance to EU MDR project teams.
Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU commercial release.
Lead the submittal of the EU MDR technical documentation for Class III, IIa, or IIb medical devices and collaborate with the cross-functional team and Notified Body to respond to any questions during the review.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

Required profile