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Job Requirements of Regulatory Affairs Specialist:
-
Employment Type:
Contractor
-
Location:
Chaska, MN (Onsite)
Do you meet the requirements for this job?
Regulatory Affairs Specialist
Careers Integrated Resources Inc
Chaska, MN (Onsite)
Contractor
Pay Rate: $42.5/hr.
Job Description: Remote but local as candidate may need to be onsite on occasions.
Shift: mon-fri 8-5.
Top 3 Must Have Skills:
•Understanding of IVDR regulations and registration process
•Understanding of Design Change Process and applicable quality and regulatory requirements
•Health Canada and EU submission experience
individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for post-market activities. Primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities and design change evaluations. Additionally, this position supports regulatory strategy for new product development activities and applicable submissions or registrations.
This position is in the Hematology Regulatory Affairs team and reports to the Director of Regulatory Affairs. This role is responsible for managing regulatory initiatives, and working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. This position will lead and support change to legal manufacturer designation for Beckman products.
If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization read on.
In this role, you will have the opportunity to:
Manage IVDR Technical Files in compliance
Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.
The essential requirements of the job include
Bachelor's Degree with 3+ years of experience in Life Sciences or a Master's Degree with 1+ Years of experience in Life Sciences
Subject matter expertise in registration and commercialization of in vitro diagnostic medical devices
Demonstrated experience leading design change teams for RA.
This is also a plus:
Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.
Strong Health Canada, and EU submission experience
Job Description: Remote but local as candidate may need to be onsite on occasions.
Shift: mon-fri 8-5.
Top 3 Must Have Skills:
•Understanding of IVDR regulations and registration process
•Understanding of Design Change Process and applicable quality and regulatory requirements
•Health Canada and EU submission experience
individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for post-market activities. Primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities and design change evaluations. Additionally, this position supports regulatory strategy for new product development activities and applicable submissions or registrations.
This position is in the Hematology Regulatory Affairs team and reports to the Director of Regulatory Affairs. This role is responsible for managing regulatory initiatives, and working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. This position will lead and support change to legal manufacturer designation for Beckman products.
If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization read on.
In this role, you will have the opportunity to:
Manage IVDR Technical Files in compliance
Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.
The essential requirements of the job include
Bachelor's Degree with 3+ years of experience in Life Sciences or a Master's Degree with 1+ Years of experience in Life Sciences
Subject matter expertise in registration and commercialization of in vitro diagnostic medical devices
Demonstrated experience leading design change teams for RA.
This is also a plus:
Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.
Strong Health Canada, and EU submission experience
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