Sr. International Regulatory Affairs Specialist
Full Time
Saint Paul, MN
Posted
Job description
Putting a new spin on your career
Working at CSI means being a part of something greater than ourselves. We think big and move fast. From creating revolutionary technologies, to working with world class physicians and teams, we don’t simply work, we save lives. We have big company drive and small company vibe where your daily impact can be felt company-wide. If you are curious, ambitious and dedicated, you will love our community. Grow with us!
Job Description:
Job Summary:
The International Senior Regulatory Affairs (RA) Specialist will ensure that CSI products and procedures achieve and maintain regulatory compliance in applicable OUS countries.
Essential Duties and Responsibilities:
- Plan and prepare documents for OUS regulatory submissions either directly by interfacing with country Regulatory Bodies, or through in-country representatives.
- Compile and maintain International documents, such as STEDs, design dossiers and technical files required by international regulatory authorities.
- Review product design and manufacturing changes for compliance with OUS applicable regulations. Notify applicable countries of significant changes and track responses.
- Review international device labeling and advertising materials for compliance with OUS applicable regulations.
- Represent the CSI regulatory perspective and interpret the requirements of OUS applicable regulations for business-critical International functional project teams.
- Communicate and coordinate OUS regulatory activities with other departments.
- Create and revise standard operating procedures (SOPs) related to the OUS 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; International Regulatory experience a plus.
- 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
Specifications/Other
- 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.
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