Sr. Regulatory Affairs Specialist
The Senior Regulatory Affairs (RA) Specialist will ensure that CSI products and procedures achieve and maintain regulatory compliance by filling several critical roles.
Essential Duties and Responsibilities:
- Plan, review and prepare documents for FDA pre-submission meetings, IDE, 510(k), and/or PMA applications.
- Compile, prepare and submit regulatory documents such as dossiers and technical files required by international regulatory authorities.
- Review product design and manufacturing changes for compliance with applicable regulations.
- Review protocols and reports to support regulatory submissions.
- Review device labeling and advertising materials for compliance with applicable regulations.
- Represent the CSI regulatory perspective and interpret the requirements of applicable regulations for business-critical cross functional project teams.
- Communicate and coordinate regulatory activities with other departments.
- Create and revise standard operating procedures (SOPs) related to regulatory processes.
Knowledge, Skills and Abilities Required for Successful Job Performance:
- Bachelor of Science degree in a Life Science (e.g. biology, chemistry, microbiology, immunology, medical technology), engineering, or related discipline
- Minimum of 5 years of experience in medical device Regulatory Affairs
- Established knowledge of FDA regulations including 510(k), IDE, PMA; Quality Systems/ISO 13485 ; labeling and advertising/promotion
- Must be self-motivated, work independently and take full ownership of his/her responsibilities
- Strong oral communication and interpersonal skills
- Proficient in technical writing
- Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously
- Experience with EU and/or other international medical device regulations and submissions preferred.
- We are a fast growing company with lots of opportunities for growth.
- Normal office environment
CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.