Regulatory Affairs, IFU Specialist

Job description

Mitek Sports Medicine, part of the DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs, IFU Specialist - Mitek Sports Medicine located in Raynham, MA .

DePuy Synthes Mitek is the Sports Medicine business offering orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we have created one organization with a focus on activating insights to develop innovative, comprehensive healthcare solutions.

Overall Responsibilities
· To support Regulatory team by creating, updating and processing IFUs to meet regulatory compliance.
· Works with IFU Coordinator to meet IFU requirements for base business and new product development and ROW compliance.
· Provides administrative support for IFU traceability and IFU special projects. Working with Regulatory Affairs Specialists and cross-functional project teams to develop information for new IFUs.
· Responsible for the overall coordination, development and execution of IFUs/Manuals for all medical devices within the DePuy Synthes Mitek portfolio. Includes:
· Working with cross-functional teams
· Managing technical reviews of IFU drafts
· Creation of new IFUs/Manuals associated with new product development.
· Revision of existing IFUs/Manuals.
· Responsible for leading IFU special projects (i.e. MDR).
· Responsible for supporting the development of solutions for labeling initiatives/special projects, including:
· IFU content and design
· Country specific requirements
· Process improvement techniques
· Responsible for processing IFU change orders via the Change Order process.
· Responsible for keeping IFU matrix current within a validated database.

Functional and Technical Competencies :

· Basic understanding of compliance and regulatory requirements.
· Technical Writing and editing if preferred.
· Strong analytical skills (creating and following procedures) and solving procedural roadblocks
· Flexibility – able to adapt to compliance cycle activities and demanding timelines
· Strong team player – will need to collaborate with Regulatory Affairs teams, in addition to other cross-functional team members
· Excellent written and verbal communication and the ability communicate effectively with all levels of the organization.
· Familiarity with document or content management systems concepts a plus.


Leadership Competencies :

· Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal networks with cross-functional partners to identify opportunities and open communication channels
· Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact.
· Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
· Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver on-time results

Desired profile

Qualifications :

·  Bachelor degree is required.
·  4 years of practical experience is required, 2+ years in a regulated medical device environment is preferred.
·  Knowledge of International medical device labeling standards (ISO 15223-1) is preferred.
·  Experience working as a member of a team in a timeline-driven environment with limited supervision is required.
·  Managing multiple competing priorities at same time is required.
·  Excellent written, verbal communication and presentation skills are required.

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.