Regulatory Affairs Specialist II

5 days ago


Chaska, Minnesota, United States Sunrise Systems Full time
{"title": "Regulatory Affairs Specialist II", "description": "Job Summary

At Sunrise Systems, we are seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for coordinating, facilitating, and reporting on post-market regulatory programs.

Key Responsibilities
  • Coordinate and manage post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements.
  • Implement 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.
  • Prepare and maintain regulatory licenses, reports, and listings.
  • Support the IA business units in meeting global registration requirements.
  • Investigate and resolve compliance problems, questions, and complaints.
Requirements
  • 3-5 years of experience in diagnostic regulatory affairs, IVD/IVDR knowledge, global registrations (EU, Canada, Brazil, Latin America, Asia).
  • 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.

What We Offer

At Sunrise Systems, we offer a dynamic and challenging work environment, competitive compensation and benefits package, and opportunities for professional growth and development.

"}

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