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Senior Regulatory Manager
2 months ago
Job Title: Senior Regulatory Manager
Company: Singular: Building Brilliant Biotechs
Job Summary:
We are seeking a highly experienced Senior Regulatory Manager to join our team at Singular: Building Brilliant Biotechs. As a Senior Regulatory Manager, you will be responsible for ensuring regulatory compliance and advancing our groundbreaking technology in the field of cancer diagnostics.
Key Responsibilities:
- Regulatory Strategy and Planning: Contribute to the development of regulatory strategies and plans to achieve project goals.
- Study Management: Design and oversee analytical and clinical verification/validation studies to ensure compliance with regulatory requirements.
- Regulatory Submissions: Liaise with regulatory authorities to create and submit device registration materials, ensuring timely and accurate submissions.
- Post-Market Surveillance: Manage surveillance activities to meet regulatory requirements, ensuring ongoing compliance and quality.
- Compliance Review: Review product promotional materials and external content for compliance with regulatory requirements.
- Quality Support: Support the ISO13485 quality system and secure/maintain quality accreditations, ensuring adherence to regulatory standards.
Requirements:
- Experience: Proven track record of developing regulatory pathways and obtaining global approvals for medical device product development.
- Knowledge: In-depth knowledge of global medical device directives, regulations, and standards, including ISO 14971.
- Skills: Highly detail-oriented with a flexible, can-do approach, capable of managing multiple projects simultaneously.
What We Offer:
- Innovative Environment: Be part of a team working on revolutionary cancer diagnostics technology, driving innovation and excellence.
- Career Growth: Gain valuable experience in a cutting-edge biotech company, with opportunities for professional development and advancement.
- Collaborative Culture: Join a team that values innovation, collaboration, and shared excellence, fostering a culture of continuous improvement.
