Advantage Technical
Regulatory Affairs Specialist - IVDR Transition
Join our client’s mission to bring quality diagnostics to labs around the world.
As a
Regulatory Affairs Specialist , you will play a vital role in supporting the EU’s
In Vitro Diagnostic Regulation (IVDR)
transition—ensuring the company’s CE‑marked products continue to meet the highest global standards of safety, quality, and compliance. This is an exciting opportunity for someone who enjoys working at the intersection of science, regulation, and innovation, and who takes pride in building the documentation and structure that make regulatory excellence possible.
How You’ll Make an Impact
Support the IVDR transition
for all CE‑marked products by preparing and revising technical files to the latest standards.
Generate comprehensive technical files that clearly present product characteristics, performance data, and evidence of conformity using the most recent templates and documentation requirements.
Collaborate cross‑functionally
with Quality, R&D, Manufacturing, and Regulatory teams to ensure all documentation is accurate, complete, and delivered within defined timelines.
Participate in
weekly project meetings
to address technical questions, track progress, and maintain alignment with project managers.
Support labeling conversion projects—updating specifications, conversion logs, and ensuring compliance with IVDR requirements.
Assist in
un‑CE marking activities , ensuring product labeling reflects the updated regulatory status and is aligned with specification documents.
Update tracking logs, coordinate regional notifications, and communicate with the
RA SAP restriction coordinator
to manage product distribution restrictions where necessary.
What You Bring
Bachelor’s degree
in Biochemistry, Biology, Medical Technology, or a related scientific field.
3‑5 years
of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD or medical device industry.
Solid understanding of
FDA and CE‑marking requirements
for IVD products (IVDR knowledge strongly preferred).
Excellent
communication, analytical, and problem‑solving skills , with the ability to work both independently and collaboratively.
Strong
attention to detail , organization, and ability to manage multiple tasks within set deadlines.
Proficiency with
Microsoft Office, document control systems, and regulatory databases .
Benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E‑Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI‑generated and non‑AI‑generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
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Regulatory Affairs Specialist , you will play a vital role in supporting the EU’s
In Vitro Diagnostic Regulation (IVDR)
transition—ensuring the company’s CE‑marked products continue to meet the highest global standards of safety, quality, and compliance. This is an exciting opportunity for someone who enjoys working at the intersection of science, regulation, and innovation, and who takes pride in building the documentation and structure that make regulatory excellence possible.
How You’ll Make an Impact
Support the IVDR transition
for all CE‑marked products by preparing and revising technical files to the latest standards.
Generate comprehensive technical files that clearly present product characteristics, performance data, and evidence of conformity using the most recent templates and documentation requirements.
Collaborate cross‑functionally
with Quality, R&D, Manufacturing, and Regulatory teams to ensure all documentation is accurate, complete, and delivered within defined timelines.
Participate in
weekly project meetings
to address technical questions, track progress, and maintain alignment with project managers.
Support labeling conversion projects—updating specifications, conversion logs, and ensuring compliance with IVDR requirements.
Assist in
un‑CE marking activities , ensuring product labeling reflects the updated regulatory status and is aligned with specification documents.
Update tracking logs, coordinate regional notifications, and communicate with the
RA SAP restriction coordinator
to manage product distribution restrictions where necessary.
What You Bring
Bachelor’s degree
in Biochemistry, Biology, Medical Technology, or a related scientific field.
3‑5 years
of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD or medical device industry.
Solid understanding of
FDA and CE‑marking requirements
for IVD products (IVDR knowledge strongly preferred).
Excellent
communication, analytical, and problem‑solving skills , with the ability to work both independently and collaboratively.
Strong
attention to detail , organization, and ability to manage multiple tasks within set deadlines.
Proficiency with
Microsoft Office, document control systems, and regulatory databases .
Benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E‑Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI‑generated and non‑AI‑generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
#J-18808-Ljbffr