Job Title: Regulatory Affairs Specialist II
Location: Chaska MN 55318
Duration: 12 Months
The Staff Regulatory Affairs Specialist position requires a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities and managing complex issues that may have significant impact on the business. This individual contributor will manage global regulatory initiatives.
- The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs for adverse event, vigilance and recall reporting.
- 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. -
- , monitors and controls Regulatory project schedules related to post market activities
- Key accountability is to maintain global regulatory compliance programs for product corrective action, adverse event reporting and vigilance requirements.
- Coordination of on-going regulatory activities with Corporate Quality and Regulatory Affairs and coordinating and communicating with domestic and international business partners and direct interaction with regulatory agencies on post-market product issues and questions
- Implements, facilitates, and reports on Client's regulatory programs.
- 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.
- Bachelor's degree in sciences, engineering, or technical field and 9 years of relevant experience or a master's degree and 7 years of relevant experience or PhD and 4 years of relevant experience for STAFF level.
- 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.