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Regulatory Affairs Specialist II

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

5 years experience in diagnostic regulatory affairs, Bachelor's, Master's, or PhD degree, Regulatory experience in medical device industry, Experience with medical devices and pharmaceuticals, Familiarity with LEAN principles and risk management.

Key responsabilities:

Coordinate and report on post-market programs
Support global registration requirements
Interpret and advise on regulations
Investigate and resolve compliance issues
Prepare and maintain regulatory documentation

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

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.

Requirements:

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.