Associate Director Regulatory developing and implementing worldwide regulatory strategies for new products at Grifols. Leading interactions with regulatory authorities and advising cross - functional teams.
About the role
- Regulatory Affairs Specialist ensuring compliance for IVD products. Collaborate with teams to develop regulatory strategies and prepare submissions to FDA and EU authorities.
Responsibilities
- Ensuring regulatory compliance for IVD products
- Developing and executing regulatory strategies
- Preparing pre-market and post-market applications
- Managing communications with health agencies
- Collaborating with cross-functional teams
- Mentoring junior colleagues
Requirements
- Bachelor’s degree in life sciences, engineering, or a related field
- At least 6 years of experience in a regulated environment
- 4 years of direct experience in Regulatory Affairs
- Prior experience in the IVD or Drug/Biologics industry
Benefits
- Medical
- Dental
- Vision
- PTO
- up to 5% 401(K) match
- tuition reimbursement
Job title
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Experience level
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Degree requirement
Location requirements
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