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Lead Regulatory Affairs Expert
2 months ago
Genalyte, Inc., a frontrunner in pioneering diagnostic technologies, is in search of a proficient and driven Senior Regulatory Affairs Specialist to enhance our innovative team. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance frameworks, ensuring our revolutionary products adhere to all necessary regulations and are efficiently introduced to the market. If you are dedicated to improving healthcare through state-of-the-art technology and excel in a cooperative setting, we welcome you to contribute to our mission of transforming diagnostic testing and enhancing patient care.
Key Responsibilities- Draft, review, and enhance technical documentation for regulatory submissions, ensuring compliance with relevant guidelines.
- Coordinate and oversee Q-submissions to facilitate timely FDA feedback.
- Lead the preparation and submission processes for 510(k), PMA, and CE applications.
- Manage e-STAR regulatory submission requirements to comply with standards.
- Maintain thorough regulatory documentation, including 510(k)s, PMAs, Q-Submissions, and CE dossiers for the EU.
- Develop and oversee labeling documents for regulatory submissions.
- Collaborate with various departments to convey regulatory requirements and monitor submission timelines.
- Provide strategic regulatory insights and analysis to support the team.
- Ensure the accuracy and currency of regulatory registrations, certifications, and licenses.
- Stay informed on regulations and guidance documents to maintain ongoing compliance.
- Assist with external regulatory agency audits, offering insights to avert compliance issues.
- Organize and meticulously maintain all regulatory-related documentation.
- Adhere to the company's Quality Management System (QMS).
- Perform additional responsibilities as assigned, contributing to the overall success of the team.
- A Bachelor's degree in Science or a related field, with 5-7 years of experience in IVD regulatory affairs or a similar domain.
- Certification in regulatory affairs is advantageous.
- Strong understanding of regulations, along with excellent analytical and problem-solving abilities.
- Exceptional written and verbal communication skills, with the capacity to listen, articulate, and advocate effectively.
- Proficient prioritization skills, adaptability, and the ability to manage multiple projects concurrently while meeting deadlines.
- Effective communication skills with colleagues across various departments.
- Proficient in Microsoft Office Suite - MS Word, Excel, and PowerPoint.
- Strong organizational skills and attention to detail, with the ability to handle numerous projects under tight timelines.
At Genalyte, we prioritize the well-being and success of our employees. As a valued member of our organization, you will enjoy a comprehensive benefits package, including a competitive salary, health, dental, and vision insurance, along with flexible paid time off. We also offer stock ownership and equity participation, allowing you to share in the company's success and growth. Join us in shaping the future of healthcare while building a fulfilling career.
