Regulatory Affairs Specialist

• Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. 

• 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. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.

• Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.

• Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.

• Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.

• Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.

• Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.

• Determining and communicating submission and approval requirements.

What you need:

Required-

• Bachelor's or Master’s degree in Regulatory Affairs, Engineering or equivalent discipline is required.

• 3 - 5 years experience

Preferred-

• Experience with post-market and change management is a distinct advantage

• RAC Certification is preferred