Sr. Principal, Regulatory Affairs
Position Overview
Responsible for developing, leading, and implementing strategic goals established by functional leadership for worldwide product approval submission activities. As a recognized master in professional discipline, prepare strategy for worldwide product approval submission activities. Responsible for submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:
- Serve as a senior Regulatory representative on project teams and partner with functional unit Regulatory Affairs Specialist (RAS) to provide regulatory support for new and marketed products.
- Define the global regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
- Lead the preparation of regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
- Work independently with RAS, engineers, and subject matter experts (SME) to implement strategic goals and resolve potential regulatory issues and questions/ deficiencies from regulatory agencies.
- Strongly influence the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results.
- Interact directly with regulatory agencies at reviewer level. Lead negotiations and interactions during the review process.
- Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
- Review change order documents and ascertain impact on current regulatory approvals.
- Provide regulatory input to product lifecycle planning, in particular, business integration or acquisitions.
- Review promotional material and labeling for regulatory compliance.
- Develop and maintain regulatory files and records. 12. Develop, edit, or revise regulatory processes.
- Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions.
- Lead training for global regulatory processes and system implementations.
- Build team cohesiveness by influencing and mentoring team members.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- Bachelor’s degree in a scientific or technical discipline or relevant field of study.
- Minimum ten (10) to fifteen (15) years of professional regulatory experience.
- Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or rest of the world (ROW) registrations across product lines.
- Demonstrated knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication, and collaboration internally and externally with respect to submissions, registrations, obtaining approval/clearance, and post marketing compliance.
- Prior direct involvement interfacing with regulatory authorities through regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
- Detail oriented.
- Excellent written and verbal communication skills.
- Proficient computer skills, including MS Word, Excel, PowerPoint, Outlook, and Teams.
- Advanced degree in a scientific or technical discipline or relevant field of study.
- Experience in leading large sized project teams across multiple product lines.
- Ability to work well in a team environment.
- Proven technical abilities; analytical and organization skills.
- Ability to comprehend technical documents and concepts.