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Lead Regulatory Affairs Consultant
2 months 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 is pivotal in implementing strategies and managing operations related to regulatory affairs, which includes overseeing the preparation of product registration submissions, progress reports, and amendments.
Key Responsibilities:
- Compile and maintain submissions for US 510k and EU IVDR Technical Files.
- Ensure compliance with relevant corporate and divisional policies under the quality management system.
- Prepare and review regulatory submissions for both US and EU markets.
- Identify and address regulatory challenges and emerging issues during the product submission process.
- Provide regulatory insights for product lifecycle planning across designated regions.
- Monitor the status of applications under regulatory review and communicate updates to stakeholders.
- Submit necessary reports and ensure timely responses to regulatory authorities.
- Utilize technical expertise to propose solutions for complex regulatory challenges.
- Assess the adequacy of quality, preclinical, and clinical documentation for submission.
- Offer strategic guidance on regulatory requirements to development teams.
Leadership Responsibilities:
This role involves providing guidance and direction to team members without direct authority, fostering collaboration and ensuring project objectives are met.
Accountability and Scope:
The individual will independently manage technical and scientific regulatory activities, ensuring compliance with deadlines and effectively communicating with regulatory agencies. This position requires a thorough understanding of regulatory requirements and the ability to interpret and apply them appropriately.
Qualifications:
A Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Engineering) is preferred. An advanced degree or relevant certification (such as RAC) is advantageous. A minimum of 5 years of experience in a regulated industry, particularly in medical devices or pharmaceuticals, is required. Experience with US 510k submissions or EU MDR/IVDR technical files is highly desirable.
