The VP, Regulatory Affairs will provide strategic and operational leadership to the regulatory team, lead regulatory strategy for the company from regulatory path planning to submission and post market change assessment, manage government regulations, monitor regulatory proceedings, and maintain positive government engagement. Interface with agency officials to actively understand and stay ahead of the rapidly growing global regulatory environment and improve the overall business impact of regulatory decisions.
Major Duties and Responsibilities:
- Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in all major global markets.
- Defines country-specific regulatory strategies for all programs, assessing optimal route to approval, leading communication and negotiation with global regulatory agencies, and leading the company’s effort in definitive submissions.
- Provides strategic regulatory leadership for all clinical development projects, including but not limited to, overall global regulatory strategy, regulatory requirements for registration in domestic and international markets, and regulatory risk assessments and mitigation for all Company programs.
- Leads communications with regulatory agencies. Prepares briefing and regulatory documents for regulatory agencies, such as Design Dossiers, 510(k)s, PMAs, and IDEs. Responds to regulatory agencies with intelligence and diplomacy.
- Ensures that all nonclinical and clinical programs, and clinical trials are appropriately informed and structured to meet US, European, and other regulatory requirements.
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise, and relevant information.
- Provides guidance and information to the Senior Management Team on emerging trends, regulations, and health authority guidelines to ensure use of the desired regulatory strategies.
- Provides counsel, training and interpretation of FDA and other regulatory requirements to all. Development staff members and where appropriate to other teams and individuals. Cultivates an atmosphere of transparency and problem-solving that encourages requests for advice and input by company staff.
- Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations.
- Develops and maintains strong relationships with key stakeholders and regulatory officials.
- A strong collaborative leader with experience building, leading and managing a regulatory team as well as experience with cost effective management of outside regulatory resources.
- Possess a positive, people-centric leadership style and have a track record of enhancing a culture where people love to work, grow their capabilities, and do their best work in pursuit of a vision.
- Actively promote a healthy work environment and adhere to SRM Employment/Safety policies and procedures.
- Provide a solid vision for team by effectively communicating job expectations, providing feedback and advice and staff training.
- Proven leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done.
- BS in technical discipline with a preference for M.S. or equivalent.
- A strategic thinker with a minimum of 15+ years’ experience in regulatory, with a medical device company; strong preference for someone who has worked in a start-up in the cardiovascular/ednovascular industry
- 10+ years of direct regulatory affairs experience and with international regulatory agencies is highly desired.
- 5+ years direct supervision experience including managing staff performance, coaching and teamwork.
- Exceptional verbal, written and executive-level presentation skills, professional, and diplomacy skills.
- Must be comfortable in an entrepreneurial environment with limited support while expanding a team.
- Demonstrated ability to interface with relevant regulatory authorities.
- Creative problem-solver and change-driver who anticipates trends, presents new ideas, and drives change management.
- Strong track record of partnering with cross-functional teams to ensure the regulatory strategy is fully integrated into the broader business strategy.
- Ability to communicate and present to all levels.
- Ability to analyze, solve problems, exceptional attention to details, processes and prioritize sensitive complex information.
- Ability to travel up to 25% (domestic & international).