- Ensures promotion of awareness of regulatory and customer requirements throughout the organization.
- Hosts regulatory body audits.
- Leads the execution of the regulatory submission and approval effort with strategic vision and sound strategies.
- Implements company regulatory strategies for the development of new products and product enhancements to achieve marketable products in an efficient and effective manner. Personally, directs the assembly of all components of regulatory applications.
- Maintains outstanding relationships with all key internal customers and regulatory agencies. Interacts with the FDA (and international regulatory agencies) on a proactive, independent, and frequent basis. Also interacts with any internal or external organizations involved with regulatory compliance.
- Oversees implementation of quality procedures and protocols that ensure compliance and product reliability.
- Reviews product development, bench testing, animal testing, quality assurance, manufacturing, quality system, marketing, and clinical research study reports and other regulatory documents.
- Evaluates external business development opportunities from a regulatory and scientific perspective and provides feedback.
- Manages Regulatory budgets for all submission activities.
- Staffs/manages Regulatory personnel.
- Oversees the management of MDR/Vigilance reporting of company products.
- Ensures appropriate communication processes are established within and across functional groups.
- Hiring and supervisory responsibilities as the department develops.
- Bachelor’s in Engineering or Life Sciences and 15+ years of medical device industry experience, including 7+ years of technical management responsibilities.
- Previous experience in the development and execution of regulatory strategies leading to medical device market clearance/approval is required.
- Applied knowledge of FDA QSR, ISO 13485 and Medical Device Regulations are required.
- Regulatory Affairs Certification (RAC), MD or PhD desired.
- Excellent communications skills (both written and verbal) required.
- Excellent presentation skills are required.
- Ability to work independently or in team setting required.
- Ability to travel as needed.
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