Lead Regulatory Affairs Consultant
2 weeks ago
Position: Senior Regulatory Affairs Specialist
Company: Intellectt Inc
Role Overview:
The Senior Regulatory Affairs Specialist will engage with various business units to enhance and refine regulatory processes. This role involves assisting in the strategic implementation and operational activities related to regulatory affairs, including overseeing the preparation of product registration submissions, progress updates, and necessary amendments.
Key Responsibilities:
- Compile and maintain submissions for US 510k and EU IVDR Technical Files.
- Ensure adherence to relevant Corporate and Divisional Policies within the quality management system.
- Prepare and review regulatory submissions for both US and EU markets.
- Proactively identify regulatory challenges and collaborate with cross-functional teams to devise solutions.
- Provide regulatory insights for product lifecycle management in designated regions.
- Track applications under regulatory review and relay progress to internal stakeholders.
- Submit required reports and ensure timely responses to regulatory bodies.
- Utilize regulatory expertise to propose strategies for complex regulatory issues.
- Evaluate the acceptability of quality, preclinical, and clinical documentation for submission.
- Assess the impact of design changes on registration in relevant regions.
- Offer strategic guidance on regulatory requirements to development teams.
- Ensure that external communications for regulatory purposes comply with regulations.
Leadership Responsibilities:
This role requires providing leadership without direct authority, guiding both exempt and non-exempt personnel who operate with significant independence.
Accountability and Scope:
The individual will manage technical and scientific regulatory activities independently, ensuring deadlines are met while effectively communicating with various regulatory agencies. The role demands a thorough understanding of regulatory requirements and the ability to apply them appropriately.
Qualifications:
A Bachelor's Degree in a relevant scientific field is preferred, with a Master's Degree being advantageous. Certification in regulatory affairs is a plus.
Experience:
A minimum of 5 years in a regulated industry, such as medical devices or pharmaceuticals, is required. Experience with US 510k submissions or EU MDR/IVDR technical files is highly desirable, along with practical experience in leading cross-functional regulatory projects.
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