Job Description

Job Title: Regulatory Affairs Specialist II

OnSite @Chaska location

Mon-Fri 8 to 5

7:30 AM to 4:30 PM - Flexible

Duration: 12 months on Contract

Skills required for this position:

1. Regulatory experience in Medical Device Industry i.e Post Market Activities; field actions (recalls), supporting international registrations, and design change evaluations.

2. Communication skills/Team Player to establish strong working relationships with cross-functional teams.

3. Critical thinking and problem-solving

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 Client
• 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.

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