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Lead Regulatory Affairs Expert
2 months ago
Genalyte, Inc., a pioneer in innovative diagnostic solutions, is in search of a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your knowledge to navigate intricate regulatory frameworks, ensuring our revolutionary products adhere to all regulatory standards and are efficiently introduced to the market. If you are dedicated to advancing healthcare through state-of-the-art technology and excel in a collaborative setting, we welcome you to contribute to our mission of transforming diagnostic testing and enhancing patient care.
Key Responsibilities- Develop, review, and refine technical documentation for regulatory submissions, ensuring compliance with relevant guidelines.
- Coordinate and oversee Q-submissions to facilitate timely FDA responses.
- Lead the preparation and submission processes for 510(k), PMA, and CE applications.
- Manage e-STAR regulatory submission requirements to meet established standards.
- Maintain thorough regulatory files, including 510(k)s, PMAs, Q-Submissions, and CE dossiers for the EU.
- Create and manage labeling documents for regulatory submissions.
- Collaborate with various departments to convey regulatory requirements and monitor submission deliverables in accordance with project timelines.
- Provide strategic regulatory guidance 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 mitigate non-compliance risks.
- Organize and meticulously maintain all regulatory-related documentation.
- Adhere to the company's Quality Management System (QMS).
- Perform additional duties as assigned, contributing to the overall success of the team.
- A minimum of 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 coupled with excellent analytical and problem-solving abilities.
- Exceptional written and verbal communication skills, with the capacity to listen, articulate, and advocate effectively.
- Strong prioritization skills, adaptability, and the ability to manage multiple projects simultaneously while meeting deadlines.
- Ability to communicate effectively with colleagues across various departments.
- Proficient in Microsoft Office applications, including MS Word, Excel, and PowerPoint.
- Strong organizational skills and attention to detail, with the capability to handle several 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 benefit from a comprehensive package that includes a competitive salary, health, dental, and vision insurance, along with flexible paid time off. Additionally, we offer stock ownership and equity participation, allowing you to share in the success and growth of the company. Join us in shaping the future of healthcare while building a fulfilling career.
