Director, Regulatory Affairs
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for a Director, Regulatory Affairs to join our Orthopaekics team located in Palm Beach Gardens, FL, West Chester, PA, Warsaw, IN or Raynham, MA. Purpose: The Director, Regulatory Affairs is responsible for setting regulatory strategy, and in partnership with cross-functional teams, driving excellence in product innovation, launch and portfolio management. This position is also responsible for providing direction and leadership to the Regulatory Staff in the development and implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations.
Requirements
- Minimum of a Bachelors’ degree within a technical related discipline is required.
- Minimum 10 years relevant / regulated industry experience is required.
- Previous experience with medical devices and digital surgical robotics is strongly preferred.
- Senior leadership experience is required, including line management of multiple levels of reporting.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
Nice To Haves
- M.S., M.E., PhD or MD is highly preferred.
Responsibilities
- Leads and manages activities concerned with the submission and approval products to government regulatory agencies. Develops world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
- Administers Regulatory Affairs operations including setting strategic direction and communicates business goals and objectives.
- Oversees the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of orthopaedic products, including Class III devices.
- Defines the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget
- Partners with R&D, Quality, Supply Chain, Global Strategic Marketing leaders and other cross-functional leaders to develop and implement strategy for pipeline development and global launch excellence
- Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of product lifecycle management
- Lead and develop Regulatory staff to become future leaders
- Partners with Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs to management
- Establish and ensure deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements.
- Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
- Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements
- Assures timely regulatory clearances for key product launches in all key markets and assesses the current state of the department (organizational structure, competencies and skills) and implements a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
- Inspires, motivates and communicates vision to regulatory associates, peers.
- Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member)
- Represent Johnson & Johnson’s strategic focus area in various internal and external forums and strategy/interactions
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
