Regulatory Affairs Director
1 week ago
Lead Regulatory Strategies for Global Impact
As a Senior Manager in Regulatory Affairs at Jacobs Management Group, you will be at the forefront of innovation in the medical device industry. You will shape the future of healthcare by ensuring compliance with FDA and Health Canada regulations, and by leading a dynamic team focused on continuous improvement.
Key Responsibilities:
- Develop and implement regulatory strategies for cutting-edge medical devices.
- Collaborate with cross-functional teams to drive product success.
- Manage and mentor a team of regulatory affairs professionals.
- Provide regulatory guidance on product development and marketing strategies.
- Oversee regulatory procedures and implement continuous process improvements.
Requirements:
- 7+ years of progressive experience in regulatory affairs.
- Must have experience with in vitro diagnostics (IVDs)
- Thorough understanding of FDA, Health Canada regulations, and the 510(k) process.
- Expertise in Hematology, Urinalysis, Flow Cytometry, and Coagulation is a plus.
- Ability to communicate complex scientific data effectively.
- Proven leadership skills with experience in team management.
About Jacobs Management Group:
- We are a leading management consulting firm that helps companies navigate complex regulatory environments.
- We are committed to delivering high-quality solutions that meet the needs of our clients.
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