Description
A global leader in in-vitro diagnostics technology is seeking a Senior Manager to join their evolving and growing Regulatory Affairs team. The Senior Manager will be responsible for the strategy and global submissions for a product lifecycle group.Responsibilities:
- Develop global regulatory strategies for new and existing in-vitro diagnostic products
- Serve as regulatory team member on development teams, assessing product changes and developments and their regulatory impact.
- Write and file regulatory submissions, including PMA and/or BLA submissions and supplements.
- Serve as subject matter expert on global standards, regulations and guidances
Requirements:
- 5+ Years Regulatory Affairs Experience (with class III devices or IVD's)
- Experience with Blood Screening a plus
- Bachelor's Degree (scientific field a plus)
- RAC preferred