Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Hospital laboratories are our core clinical diagnostic customers. Our life science customers include pharmaceutical and biotechnology companies, universities, medical schools and research institutions. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, our products have been making a difference in peoples' lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
The Senior Regulatory Affairs Analyst is responsible for executing the post-market regulatory strategy and deliverables for all Beckman Coulter product lines.
Prepare and submit adverse event and product corrective action (recall) reports to FDA, Health Canada, EU Competent Authorities, and other regulatory agencies.
Prepare responses to regulatory agencies’ inquiries regarding adverse event reports and recalls.
Provide high level of support during internal and external audits.
Maintain current knowledge of global regulation impacting post-market activities. Apply knowledge and suggest improvement to current processes as needed.
Participate in training colleagues.
Represent Global Regulatory in cross-functional projects.
Perform other related duties and assignments as required.
Demonstrated ability to perform detail-oriented work with a high degree of accuracy.
Working knowledge of US and international regulations (FDA 21 CFR, CMDCAS ISO 13485, IVDD, MDD).
Excellent organization, planning, and execution skills.
Excellent oral and written communication skills.
Effective analytical and problem solving skills.
Master’s degree in Science or Regulatory Affairs with 2 years of experience or Bachelor’s degree in Science or Regulatory Affairs with 6 years of experience.
Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.
Legal & Compliance
North America-United States-CA-Brea
Danaher - 2 years ago