Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Sr. Regulatory Affairs Analyst for a 12-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Viewed as team regulatory resource.

Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Viewed as team regulatory resource.

RESPONSIBILITIES:

• Ensuring regulatory compliance by completing thorough assessments and submitting appropriate documentation pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory agencies.
• Working with minimum supervision, exercising some autonomy for independent actions or decisions, conferring with senior and supervisory staff when needed, and keeping supervisors regularly informed on work status.
• Developing and applying fundamental knowledge and understanding of regulatory and legal frameworks, requirements, legislation, processes, and procedures.
• Managing projects, writing, coordinating, and executing regulatory items.
• Completing technical and scientific regulatory assignments that are broad in scope.
• Working with minimal supervision, consulting with superiors on unusual matters.
• Handling broad, complex assignments that require originality and ingenuity.

REQUIREMENTS:

• Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related fields
• 2-3 years of hands-on experience in regulatory compliance within the healthcare or life sciences industry
• RAC (Regulatory Affairs Certification) or Advanced Degree such as a Master's in Regulatory Affairs
• Previous experience working on regulatory submissions with Notified Bodies or other international agencies
• Additional language skills or familiarity with global market regulations