Regulatory Affairs Director
2 months ago
Lincolnshire, Illinois, United States
Jacobs Management Group
Full time
Senior Manager, Regulatory AffairsAt Jacobs Management Group, we're seeking a seasoned Senior Manager to lead our regulatory affairs efforts. As a key member of our team, you'll be responsible for shaping our regulatory strategies and ensuring compliance with FDA and Health Canada regulations.
Key Responsibilities:- Develop and implement regulatory strategies for 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.
- 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.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
We're excited to hear from you Please submit your application, and we'll be in touch to discuss further.