Regulatory Affairs Specialist - Sunrise Systems Inc
Chaska, MN 55318
About the Job
Job Title: Regulatory Affairs Specialist
Reference ID: 24-04656
Location: Chaska, MN
Duration: 12 Months
Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)
Responsibilities:
Minimum qualifications:
Reference ID: 24-04656
Location: Chaska, MN
Duration: 12 Months
Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)
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.
Minimum qualifications:
- 3-5 YEARS EXPERIENCE IN DIAGNOSTIC REGULATORY AFFAIRS IVD / IVDR KNOWLEDGE, GLOBAL REGISTRATIONS (EU, CANADA, BRAZIL, LATIN AMERICA, ASIA PAC .
- Bachelor’s degree in sciences, engineering, or technical field and 5 years of relevant experience or a Master’s degree and 2 years of relevant experience or PhD and 1 year of relevant experience for SENIOR level.
- 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 : Sunrise Systems Inc
