Director, Business Development Regulatory Affairs

Working

Location:

Massachusetts, Westborough;
Nationwide

Workplace Flexibility:

Remote

The Director, BD Regulatory Affairs is responsible for strategic and tactical functional support for business development projects. This important role will be a key partner to the global BD team, ensuring that the function’s perspective is embedded in diligence and integration efforts.

• Serve as the global liaison between RA and the BD team.
• Responsible for providing in‑depth analysis of Medical Device/Healthcare quality management system functionality and maintenance to contribute to transfer of business activities.
• Provide strategic guidance on global regulatory pathways and market access planning.
• Accountable for developing, maintaining, and executing a RA M&A readiness plan.
• Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting RA due diligence, integration strategy/planning activities, and integration execution against best practices.
• Tool & Process Development and Continuous Improvement:
  Create the tools and standard operating processes necessary to support RA efforts throughout the full business development cycle (pre deal through integration), including ownership of assigned deliverables.
• Develop a clear implementation plan, agreed to by BD and RA senior leaders.
• Resource planning and intra‑RA coordination: maintain an up‑to‑date view of all projects in the business development pipeline.
• Plan for functional support by estimating timing and resource requirements per project.
• Communicate and coordinate needs within the function to identify and obtain adequate support at global and regional levels.
• Ensure the appropriate global regulatory requirements, are considered as part of due diligence and appropriately incorporated into integration activities.
• Accountable for ensuring all regulatory documentation is maintained, well‑organized and ready to be audited by global regulatory authorities / notified bodies.
• Develop an understanding of business unit strategies and product portfolios.
• Provide Business Unit Leaders and other key stakeholders regulatory guidance strategy to assist in BD decision making, integration strategy/planning, and execution.
• Build and maintain a network of resources in all regions, across all businesses and divisions.
• Functional and Regional Alignment: coordinate with global and regional RA teams to ensure efforts are aligned, obtain approvals, and assign resources.
• Take responsibility for all RA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans.
• Stay current on industry and functional trends by reviewing the output of relevant regulatory intelligence reports and apply learning to target evaluation and integration.
• Training & coaching:
  Develop personal expertise and train RA personnel on BD tools & processes.
• Coach colleagues on how to effectively participate in due diligence and integration planning and execution.

Required:

• Bachelor’s degree in a science‑related discipline.
  
  Masters preferred.
• Minimum of 15 year of directly related Regulatory Affairs experience; preferably at least 10 years in a global role.
• Experience with global submissions and determining regulatory pathways.
• Knowledge of and experience managing a Quality Management System and leading external QMS certification/surveillance audits.
• Thorough understanding of global submission requirements and appropriate design control requirements in order to satisfy global Health Authority submission standards.
• In‑depth knowledge of global quality and regulatory requirements for the development of new product and maintenance support for sustaining market access.
• Experience in Business Development/M&A projects.
• Demonstrated ability to work cross‑functionally.
• Demonstrated ability to lead programs/projects.
• Has sense of passion, drive and perseverance to accomplish goals.
• Exc…