Specialist Regulatory Affairs
Specialist Regulatory Affairs
Posted on :
17-05-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid
What you will do
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
Bachelors or Masters degree in Regulatory Affairs Engineering or equivalent discipline is required.
3 5 years experience in an equivalent position within an R&D environment is preferred
Preferred
Experience with postmarket and change management is a distinct advantage
RAC Certification is preferred
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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