Johnson & Johnson Careers
Senior Director, J&J Medical Device Post Market Surveillance
Requisition ID: 00001DBY
Johnson & Johnson's Family of Companies is recruiting for an Senior Director, J&J Medical Device Post Market Surveillance to be located in any Medical Device location globally to support our Medical Devices businesses.
Johnson & Johnson Medical Device Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands. Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years.
You, the Senior Director, J&J Medical Device Post Market Surveillance will develop the Medical Device segment strategic direction for the processes related to medical device product post-market surveillance incorporating worldwide standards and regulations. The position will have responsibilities in planning, implementing, executing, standardizing, and managing PMS processes including product plans and reports, product signal detection, and rapid response teams to significant customer issues. This position will collaborate and partner across business and functions with Medical, Customer Quality, Product Escalations / Field actions, R&D, and Quality Engineering to oversee data trending related to product quality, safety or efficacy signals.
Responsibilities include but are not limited to:
- Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
- Act as a representative for J&J Medical Devices to US FDA, worldwide health authorities and notified bodies during audits or in external forums.
- Manage Ethicon, CSS, and DePuy Synthes teams responsible for establishing and coordinating all global post-market surveillance activities for products across those companies. This management also includes oversight of the department’s budget, as well as hiring, retaining and developing qualified personnel, and resolving all personnel issues and employee performance management.
- Act as J&J Medical Device segment lead at J&J Enterprise level to influence strategic vision of Post Market Surveillance across the company. Benchmark across industry to develop best-in-practice processes. Oversee technology/data analytics platforms supporting product data analysis and product safety signal determination to ensure compliance to regulations and standards and effective internal process flow.
- BS degree in scientific and/or engineering discipline or equivalent.
- Minimum of 10 years of related work experience; 5+ years of leadership experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry is required.
- Minimum of 5 years of supervisory/people management experience is required.
- Extensive knowledge of FDA Quality System Regulation and ISO 13485 Standard is required.
- Experience in Quality Systems Development is required.
- Experience in the Medical Device industry or medical field is required.
- FDA inspection experience in front room, defending records and/or presenting process overviews is preferred. Strong business and process efficiency acumen required.
- Ability to interpret and apply regulatory requirements and industry best practices.
- Management skills with demonstrated ability to effectively train, mentor, and influence a diverse array of employees at all levels of the organization.
- Thorough knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices.
- Excellent interpersonal skills, negotiation and influencing skills. Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel. Skilled at preparing executive briefings and broad communications.
- Ability to make solid decisions that will effectively support the business and company policies.
- Ability to work in fast paced environment and rapidly shifting priorities with business and financial acumen. Highest ethical standards and integrity.
- The position will require approximately 25% travel both domestically and internationally, depending on the location of the role.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Asia Pacific, Latin America, Europe/Middle East/Africa
Ethicon Inc. (6045)