Senior Regulatory Affairs Specialist

Genalyte, Inc., a leader in innovative diagnostic solutions, is seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate complex regulatory landscapes, ensuring our groundbreaking products meet all regulatory requirements and reach the market efficiently. If you are passionate about advancing healthcare through cutting-edge technology and thrive in a collaborative environment, we invite you to be a part of our mission to transform diagnostic testing and improve patient outcomes.

ABOUT THE ROLE

Senior Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. This role will be responsible for preparing submission documents and work cross functionally with other departments to ensure timely completion of deliverables related to regulatory submissions. Responsible for maintaining regulatory related documents.

WHAT YOU'LL DO

• Craft, review, and refine technical documents for regulatory submissions, ensuring alignment with applicable guidance.

• Coordinate and manage Q-submissions for prompt FDA responses.

• Lead the preparation and submission process for 510(k), PMA, and CE applications.

• Oversee the e-STAR regulatory submission requirements to meet standards.

• Maintain comprehensive regulatory files, including 510(k)s, PMAs, Q-Submissions, and CE dossiers for the EU.

• Develop and manage labels and labeling documents for regulatory submissions.

• Collaborate with various departments to communicate regulatory requirements and track submission deliverables according to project timelines.

• Provide strategic regulatory guidance and analysis to support the team.

• Monitor and ensure the accuracy and currency of regulatory registrations, certifications, and licenses.

• Stay updated on regulations and guidance documents to ensure ongoing compliance.

• Support external regulatory agency audits, offering regulatory insights to prevent non-compliance issues.

• Organize and maintain all regulatory-related documentation meticulously.

• Adhere to the company's Quality Management System (QMS).

• Perform additional duties as assigned, contributing to the team's success

WHAT YOU'LL NEED

• A minimum of a Bachelor's degree in Science or related discipline of 5-7 years experience in IVD regulatory or similar

• Certification in regulatory affairs is a bonus

• Excellent understanding of regulations and strong analytical and problem-solving skills

• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate

• Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines

• Ability to communicate effectively with employees across multiple departments

• Proficient in Microsoft Office applications - MS Word, Excel, and Powerpoint

• Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines.

WHY JOIN US

At Genalyte, we believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and flexible paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

SALARY RANGE: $100,000 - $120,000

Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual's skills, qualifications, business need and experience.