Regulatory Affairs Specialist ensuring compliance for IVD products. Collaborate with teams to develop regulatory strategies and prepare submissions to FDA and EU authorities.
About the role
- Associate Director Regulatory developing and implementing worldwide regulatory strategies for new products at Grifols. Leading interactions with regulatory authorities and advising cross-functional teams.
Responsibilities
- Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices
- Provides regulatory expertise to Research and Development to support the design and analysis of projects
- Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies
- Advises cross-functional teams on regulatory aspects of product development and/or lifecycle management
- Write and review documents with complex scientific information for regulatory submissions
Requirements
- Bachelor's Degree in related scientific discipline
- 12+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field
- Knowledge and understanding of global regulations for the biotechnology and pharmaceutical industry
- Excellent oral and written communication skills
- Critical thinking and problem-solving skills
- Demonstrated project management skills
- Ability to work within a global team framework and multi-cultural environment
Benefits
- Medical
- Dental
- Vision
- life insurance
- PTO
- paid holidays
- up to 5% 401(K) match
- tuition reimbursement
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