Role Description 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. Job Duties - 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. - 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. - 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. - 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: - Conducting or overseeing due diligence and integration activities. - Building a functional plan for each project to ensure that functional risks are identified, and actions are planned. - 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. - 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. Qualifications - Bachelor’s degree in a science-related discipline; Masters preferred. - Minimum of 15 years 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. - Excellent team player. - Global understanding of product domains and key technology/therapeutic area/R&D disciplines. - Excellent leadership and interpersonal skills, including the ability to work across cultures and personality types. - High business acumen: ability to learn quickly and adapt to new circumstances; comfort and ability to effectively order the unknown; intellectual agility. - Excellent communication skills, both verbal and written; ability to quickly distill complex information into actions/recommendations. - Excellent ability to read and influence senior decision makers bridging organizational complexities. - Strong project management skills, including planning, budgeting, and resource management. - Excellent understanding of the typical functional roles and responsibilities in R&D. - Practical understanding of global regulatory/quality standards and requirements. - Potential for travel up to 20% (deal-needs dependent); domestic and international. Benefits - Competitive salaries, annual bonus and 401(k) with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center. - Work-life integrated culture that supports an employee centric mindset. - Offers onsite, hybrid and field work environments. - Paid volunteering and charitable donation/match programs. - Employee Resource Groups. - Dedicated Training Resources and Learning & Development Programs. - Paid Educational Assistance.