Vice President RA/QA/CA

The Vice President of Regulatory Affairs will have a great opportunity to play a large role in the stategy and expansion of a fast-growing medical device company focused in vascular therapies.

- Responsible for Regulatory and/or Quality and/or clinical functions and staff
- Maintain and improve ISO 13485 certified quality system, and serve as lead for FDA and notified body audits/inspections
- Formulate regulatory strategies to ensure the most efficient pathways to domestic and international product clearances/approvals
- Responsible for submissions to worldwide regulatory agencies, including IRB, IDE, 510(k), CE Mark and/or PMA.
- Develop and implement regulatory strategies for product development and design changes.
- Provide regulatory support throughout product life cycle, including supporting of other functional areas, including marketing, R&D, and Clinical Affairs.
- Act as the primary interface with government authorities, including the FDA and notified bodies.
- Member of executive team, serving as the primary liaison on all regulatory affairs matters.
- Responsible for HR functions, including hiring, interviewing, performance feedback, etc.

Qualifications:

- Bachelor's Degree
- 8+ Years Regulatory Affairs Experience in the medical device industry
- Served as company Liaison (regulatory leader) with global health agencies, including FDA and notified bodies
- Strong ability to world collaboratively and strategically with cross-functional and executive management team
- Experience negotiating and/or understanding various pathways to regulatory approvals/clearances
- Understanding of vascular space (a plus)To find out more about Real Staffing please visit www.realstaffing.com