Advantage Technical
Overview
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 support the EU's
In Vitro Diagnostic Regulation (IVDR)
transition, ensuring CE-marked products continue to meet safety, quality, and compliance standards. This role bridges science, regulation, and innovation, building the documentation and structure that enables regulatory excellence.
How You 0 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 current 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 align with project managers.
Support labeling conversion projects , updating specifications, conversion logs, and ensuring IVDR compliance.
Assist in un-CE marking activities , ensuring product labeling reflects updated regulatory status and aligns 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 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 independently and collaboratively.
Strong
attention to detail , organization, and ability to manage multiple tasks within deadlines.
Proficiency with
Microsoft Office, document control systems, and regulatory databases .
Compensation and Benefits The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on factors including geographic location, experience, and performance. This posting does not promise a specific pay amount.
The range is one component of the total compensation package. Benefits typically include medical, dental, and vision plans, pre-tax savings plans, parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.
Application and About the Company After you have applied , download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. The app is available in the App Store and Google Play.
About Advantage Technical
With roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in technical resources. Services include Staff Augmentation, Direct Placement, Project Resourcing, and Outsourcing—delivered from 40 locations by over 3500 contractors to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for Clients and Talent.
EEO Statement
Advantage Technical is committed to equal employment opportunity for all persons. We will provide reasonable accommodations throughout the application, interviewing, and employment process. If you require an accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy applies to all phases of employment and related matters.
All employees are directed to familiarize themselves with this policy and to act accordingly. All decisions on employment matters will be in accordance with this policy and applicable laws.
To read our Privacy Notice for Candidates and Employees/Contractors, please refer to our Privacy Notice.
By applying for this job, you may receive calls, text messages, or emails from Staffmark Group and/or its affiliates and contracted partners. Message frequency varies. You can reply STOP to cancel and HELP for help. You can access our general Privacy Policy at Privacy Policy - Staffmark.
#J-18808-Ljbffr
Join our client's mission to bring quality diagnostics to labs around the world. As a
Regulatory Affairs Specialist , you will support the EU's
In Vitro Diagnostic Regulation (IVDR)
transition, ensuring CE-marked products continue to meet safety, quality, and compliance standards. This role bridges science, regulation, and innovation, building the documentation and structure that enables regulatory excellence.
How You 0 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 current 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 align with project managers.
Support labeling conversion projects , updating specifications, conversion logs, and ensuring IVDR compliance.
Assist in un-CE marking activities , ensuring product labeling reflects updated regulatory status and aligns 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 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 independently and collaboratively.
Strong
attention to detail , organization, and ability to manage multiple tasks within deadlines.
Proficiency with
Microsoft Office, document control systems, and regulatory databases .
Compensation and Benefits The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on factors including geographic location, experience, and performance. This posting does not promise a specific pay amount.
The range is one component of the total compensation package. Benefits typically include medical, dental, and vision plans, pre-tax savings plans, parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.
Application and About the Company After you have applied , download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. The app is available in the App Store and Google Play.
About Advantage Technical
With roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in technical resources. Services include Staff Augmentation, Direct Placement, Project Resourcing, and Outsourcing—delivered from 40 locations by over 3500 contractors to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for Clients and Talent.
EEO Statement
Advantage Technical is committed to equal employment opportunity for all persons. We will provide reasonable accommodations throughout the application, interviewing, and employment process. If you require an accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy applies to all phases of employment and related matters.
All employees are directed to familiarize themselves with this policy and to act accordingly. All decisions on employment matters will be in accordance with this policy and applicable laws.
To read our Privacy Notice for Candidates and Employees/Contractors, please refer to our Privacy Notice.
By applying for this job, you may receive calls, text messages, or emails from Staffmark Group and/or its affiliates and contracted partners. Message frequency varies. You can reply STOP to cancel and HELP for help. You can access our general Privacy Policy at Privacy Policy - Staffmark.
#J-18808-Ljbffr