Title: Senior Regulatory Affairs Specialist
Salary: $100,000 to $110,000
Summary:
A global medical device company is seeking a driven and experienced person to fill their Senior Regulatory Affairs Specialist role in their facility located in the greater Charlotte area. This person will be ensuring regulatory compliance while navigating the regulatory processes of both medical devices and pharmaceutical products. This role will also give you a great opportunity to make an impact on the company's mission to save lives.
Senior Regulatory Affairs Specialist will be responsible for…
- Staying up to date with regulatory strategies, processes, and requirements for both medical devices and pharmaceuticals
- Producing and monitoring regulatory submissions to FDA and EMA
- Ensuring regulatory compliance of promotional materials and labeling
- Collaborating with cross-functional teams to ensure compliance with entirety of product lifecycle
The Senior Regulatory Affairs Specialist should have the following qualifications:
- Bachelor's degree in STEM or related field
- Minimum of 4-7 years in regulatory affairs for medical devices, encouraged to also have experience with pharmaceuticals
- Vast experience with FDA and EU regulations
- Regulatory submissions including 510(k), PMA, IDE, NDA, and IND
- Strong project and risk management experience
- Experience with FMEA documents preferred
Benefits/Perks:
- Generous paid time off, including 15 paid holidays
- Commuter/Transit Benefits
- Tuition Assistance
- Flexible work hours
