Senior Regulatory Affairs Specialist
Division: Atrial Fibrillation Division (AFD)
Location: St Paul, MN 55117
Status: Full Time, Employee
Job Category: Biotech/R&D/Science
Work Experience: 5+ to 7 Years
Education Level: Bachelor's Degree
Career Level: Experienced (Non-Manager)
Company: St. Jude Medical
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
We are seeking a high caliber, experienced Senior Regulatory Affairs Specialist. The RA Specialist will ensure that AF products and procedures comply with regulatory agencies. The Senior RA Specialist will support NurseMate, ViewMate, EP-4, and WorkMate products for the AF division. This Senior RA Specialist will contribute on cross functional teams, partner with the FDA, lead AF regulatory projects and standards in the support of our software and hardware based product lines.
Impact this role will have:
- Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals
- Develop International Regulatory Standards for AF’s software and hardware product lines
- Prepare new product Design Dossiers for submission to Notified Bodies and Health Canada
- Prepare appropriate documentation for renewing CE mark certification
- Prepare appropriate documentation for annual renewals submitted to Health Canada
- Prepare Technical Files for products with self certified CE Marks
- Update Technical Files on annual basis
- Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations
- Core member on development teams, providing RA guidance, and project regulatory assessments
- Interface directly with FDA, Notified Bodies and Health Canada
- Communicate and coordinate regulatory activities with other departments
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control)
- Review of protocols and reports to support regulatory submissions
Required Qualifications
- BA or BS in a technical discipline with at least four years technical experience
- Five years regulatory experience
- Proven experience in managing multiple complex projects
- Working knowledge of FDA regulations including 510(k), IDE, PMA, compliance, labeling and advertising.
- Strong technical and product knowledge, including complaint and MDR trends
- Experience with international medical device regulations and submissions
- Motivating leadership and partnership skills
- Strong written and oral communication and negotiations skills
- Ability to travel to multiple sites within AF product sites
Preferred Qualifications
- Regulatory Affairs Certification (RAC)
St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.
