Regulatory Affairs Specialist - Medical Devices

We are hiring for our client in the biotechnology industry.

Duration: 12 months contract

Job Type: 100% onsite; Monday to Friday

Pay rate: $30 to 33/hr on W2 (no benefits)

Responsibilities:

• Coordinate and manage post-market regulatory reporting and compliance activities in accordance with company procedures and regulatory requirements.
• Support business units in meeting global registration requirements for medical devices, pharmaceuticals, or in-vitro diagnostics.
• Interpret federal, state, and international regulations as they apply to products, processes, and procedures, and provide strategic guidance for compliance.
• Act as a liaison with regulatory bodies, ensuring clear communication and resolution of compliance issues, questions, and complaints.
• Investigate and resolve compliance problems, ensuring timely and scientifically valid internal and external reports.
• Implement regulatory activities such as obtaining global regulatory clearances/approvals, managing device listings, fulfilling import/export requirements, and maintaining regulatory intelligence.
• Prepare and maintain regulatory licenses, reports, and listings.
• Stay informed of regulatory updates and changes to ensure ongoing compliance with global standards.

Requirements:

• 3-5 years of experience in diagnostic regulatory affairs with knowledge of IVD/IVDR and global registrations (EU, Canada, Brazil, Latin America, Asia-Pacific).
• Bachelor's degree in sciences, engineering, or a related technical field with 5 years of relevant experience, or a master's degree with 2 years of relevant experience, or a PhD with 1 year of relevant experience.
• Work experience in medical devices, pharmaceuticals, or in-vitro diagnostics is required; previous regulatory experience is highly desirable.
• Strong ability to prioritize work and learn regulatory procedures efficiently.
• Excellent communication skills to interact with internal teams and external contacts.
• Ability to collaborate with team members to resolve problems and meet regulatory goals.
• Experience with LEAN principles and risk management (FMEA/HHA) is desirable.
• RAC certification is preferred.