Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Are you an experienced Regulatory Affairs professional familiar with EU, Health Canada and FDA regulatory requirements working in the medical device field? Are you looking for great company culture and an opportunity to make a difference in a team environment? Come join MicroAire! We are dedicated to enhancing quality of life by providing innovative surgical solutions to improve surgeon and patient outcomes.
Job Description:
- Represents regulatory in New Product Development teams by establishing and implementing regulatory pathway strategies for new markets and/or products.
- Has full responsibility for maintaining European Union, and Canadian regulatory compliance for existing product portfolio and supports regulatory compliance for FDA.
Qualifications Required:
- Five plus years of applicable EU and MDR requirements for medical device experience.
- Experience in Technical Files/Documentation, CE Certifications, and Notified Body Submissions
- Experience in 510 (k) submissions and IDE's
- Bachelor's degree in a related field
Qualifications Preferred:
- Experience in MDR (Medical Device Regulation)
- Experience in regulatory affairs supporting orthopedic devices
- Experience working with medical device clinical trial management/oversight
- Experience interacting with Notified Body, FDA and Health Canada regulatory bodies
- RAC certification
About MicroAire Surgical Instruments:
MicroAire is a leading designer, manufacturer and distributor of powered surgical instruments, Customer-Centric and driven for success, MicroAire is a team dedicated to enhancing quality of life: for surgery for life.
MicroAire is located in beautiful Charlottesville Va. Home of University of Virginia and two large hospitals, Charlottesville is consistently ranked as one of the best places to live in America. We offer an excellent benefits package and compensation commensurate with experience. For more information www.microaire.com (EOE)