Director, Regulatory Affairs

6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity•West Chester, MA

About The Position

The Director, Regulatory Affairs sets regulatory strategy and partners with cross-functional teams to advance product innovation, launches, and portfolio management. The role provides direction and leadership to Regulatory Affairs staff in developing and implementing global regulatory strategies and processes that support timely commercialization in key markets and compliance with worldwide regulatory expectations. The position is based in Palm Beach Gardens, Florida; West Chester, Pennsylvania; Warsaw, Indiana; or Raynham, Massachusetts. The Director leads regulatory submissions and approvals, develops worldwide strategies for device approval and ongoing support of marketed products, and oversees Regulatory Affairs operations and strategic direction. The role is accountable for the preparation and maintenance of regulatory submissions and files across a diverse orthopaedic portfolio, including Class III devices, and defines regulatory direction for pipeline development and global launches. The Director partners with research and development, quality, supply chain, marketing, policy, and other leaders; manages resources and product lifecycle regulatory activities; and develops Regulatory Affairs staff and cross-functional regulatory capabilities. The Director monitors global regulatory developments and advises management on their impact, coordinates communications with regulatory agencies, ensures compliance with company policies and requirements, and supports timely clearances for key launches. The position also assesses departmental capabilities and implements strategic and tactical plans, represents the company in internal and external forums, and evaluates external innovation opportunities. The role calls for strategic judgment, senior-level influence, scientific and technical expertise in medical devices and/or biologics, and the ability to lead an accountable, innovative, and diverse team.

Requirements

Bachelor's degree or higher in a technical-related discipline.
At least 10 years of relevant regulated-industry experience.
Senior leadership experience, including line management of multiple levels of reporting.
Demonstrated track record developing and executing global regulatory strategies aligned with business deliverables.
Strategic thinking and ability to partner with and influence senior-level stakeholders.
Expert scientific and technical understanding of medical devices and/or biologics.
Ability to lead, develop, and motivate a diverse team of regulatory professionals.
Ability to make complex decisions in ambiguous situations.

Nice To Haves

M.S., M.E., Ph.D., or M.D. degree.
Previous experience with medical devices and digital surgical robotics.

Responsibilities

Lead and manage activities related to submitting products to and obtaining approvals from government regulatory agencies.
Develop worldwide regulatory strategies to support rapid and timely device approvals and continued regulatory support for marketed devices and other products.
Administer Regulatory Affairs operations, set strategic direction, and communicate business goals and objectives.
Oversee preparation and maintenance of regulatory submissions and files, including 510(k)s, IDEs and supplements, PMAs and supplements, HDEs and supplements, annual reports, design dossiers/change notifications, and technical files.
Define strategic regulatory direction for pipeline development and global launch excellence.
Partner with R&D, Quality, Supply Chain, Global Strategic Marketing, and other cross-functional leaders to develop and implement pipeline and launch strategies.
Exercise independent judgment, manage and balance resources across critical projects, and oversee regulatory aspects of product lifecycle management.
Lead and develop Regulatory Affairs staff, building future leaders.
Partner with Policy to monitor global regulatory developments and assess their impact on research and development programs for management.
Establish learning initiatives and train cross-functional partners on current and emerging regulatory and related requirements.
Ensure aligned and coordinated communications with global and regional or local regulatory agencies.
Ensure company policies, procedures, and practices comply with appropriate regulatory requirements.
Secure timely regulatory clearances for key product launches in key markets; assess departmental structure and capabilities and implement strategic and tactical plans.
Inspire, motivate, and communicate the vision to Regulatory Affairs associates and peers.
Identify and assess external innovation opportunities, including screening and technical due diligence, or assign these activities to team members.
Represent the company's strategic focus area in internal and external forums and strategy interactions.
Cultivate relationships with regulators in key markets and collaborate internally with R&D, Medical Affairs, Clinical Affairs, Global Strategic Marketing, and other partners.
Anticipate and influence regulatory changes in key markets to maximize patient access to innovative technologies.
Mobilize and inspire an accountable team to deliver on-time clearances while balancing enterprise-wide strategic and short-term goals.
Use scientific and technical expertise to support development and planning throughout product lifecycles and proactively address safety issues with business partners.
Foster innovative thinking, informed risk taking, intellectual curiosity, and continual learning of scientific, technological, and regulatory developments.
Educate and coach others on business plans and Regulatory Affairs strategies, and advise and challenge partners to support sound business decisions.
Make and stand behind complex decisions in ambiguous situations with significant potential organizational impact.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility for the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with specified higher allowances for employees residing in Colorado or Washington.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a 52-week rolling period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.