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