Regulatory Affairs Specialist II - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements.
- As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.
- Investigates and resolves compliance problems, questions and complaints. Ensures timely preparation of organized and scientifically valid reports both internally and externally - Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements.
- Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. - Prepares and maintains regulatory licenses, reports, and listings.
- Communication skills/Team Player to establish strong working relationships with cross-functional teams.
- Critical thinking and problem-solving.
- 5 YEARS EXPERIENCE IN DIAGNOSTIC REGULATORY AFFAIRS IVD / IVDR KNOWLEDGE, GLOBAL REGISTRATIONS (Bachelor's degree in sciences, engineering, or technical field and 7 years of relevant experience or a Masters degree and 4 years of relevant experience or PhD and 2 year of relevant experience for SENIOR level.
- Regulatory experience in Medical Device Industry i.e Post Market Activities; field actions (recalls), supporting international registrations, and design change evaluations.
- Professionals with technical skills stated below but less relevant experience may be considered for ASSOCIATE level Regulatory Affairs.
- Work experience with medical devices, pharmaceuticals and/or in-vitro diagnostic fields. Previous regulatory experience desirable.
- Ability to prioritize assigned work.
- Ability to learn regulatory procedures.
- Ability to communicate accurately with internal and external contacts.
- Ability to work with team members to resolve problems and achieve goals.
- Experience with LEAN principles desirable.
- Experience with risk management (FMEA/HHA) desirable, RAC desired.
Source : Katalyst Healthcares & Life Sciences
