Danaher Corporation Principal Regulatory Affairs Specialist (REMOTE) in New York, New York
Essential Job Responsibilities
• Interpret federal/state/international regulations as they apply to Cepheid products, processes and/or procedures.• Advise on impact of regulations, devise strategies for compliance, and liaison with regulatory bodies. Investigate and resolves compliance problems, questions and complaints.• Audit and evaluate current policies, procedures, and documentation for compliance with regulations and statutes.• Actively participate in project core teams and strive to collaboratively achieve project goals and meet timelines• Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations• Compile, prepare, review, and submit regulatory submissions including FDA pre-submissions, and 510(k) notifications• Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines.• Provide regulatory input for product lifecycle management• Interface with Engineering, Product Transfer, and Manufacturing to provide regulatory input for various continuous improvement projects• Provide guidance to junior members of the team.• Provide periodic updates on status of projects to larger cross-functional audience and leadership.
Minimum Requirements - Education
Bachelor's degree with 8+ years of related work experience OR
Master's degree in field with 6+ years of related work experience OR
Doctoral degree in field with 3+ years of work experience
Minimum Requirements - Knowledge and Skills
• Familiarity with FDA and international regulations for IVDs and/or medical devices• Experience with in vitro diagnostic products and molecular technologies• Technical writing skills and ability to review and summarize data into clearly written reports• Working experience with statistics programs (JMP/Minitab) and familiarity with data analysis interpretation• Strong inter-personal skills and an ability to effectively communicate complex ideas and concepts to a diverse audience
PREFERRED REQUIREMENTS (optional):• 510(k) and PMA experience (including annual reports, supplements)• Proficiency with Agile Product Lifecycle
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid