Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physicians office. We have a great opportunity for a Regulatory Affairs Specialist to join our team!ABOUT THE ROLEThe 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. This role will also be responsible for maintaining regulatory related documents.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to:

• Write, review, and edit technical documents for regulatory submissions in a format consistent with applicable guidance documents
• Prepare and manage Q-submissions for timely responses from the FDA
• Assist in regulatory submissions (510(k), PMA, and CE)
• Prepare and manage e-STAR regulatory submission requirements
• Maintain regulatory files such as 510(k)s, PMAs, Q-Submissions, and CE dossiers for EU
• Support preparation of labels and labeling documents for submissions
• Work with other departments and communicate regulatory submission requirements and track submission deliverables for completion as per the project timelines
• Provide support to the team with regulatory strategy analyses and options
• Monitor and maintain regulatory registrations, certifications and licenses, ensuring they are accurate and up-to-date
• Keep abreast of regulations / guidances to ensure compliance
• Support external regulatory agency audits, providing regulatory input to minimize or prevent potential findings of non-compliance
• Organize and maintain all regulatory related documents
• Comply with companys QMS
• Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• A minimum of a Bachelors degree in Science or related discipline of 4 - 5 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

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