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 Sr. Staff Regulatory Specialist develops, designs, manages and integrates Beckman
Coulter’s regulatory strategies and programs. As a regulatory process expert to
development center teams, the incumbent creates and integrates advanced regulatory
strategies for global registrations and compliance activities; provides regulatory
leadership in promotional material review, experimental designs, data analysis and
product labeling as related to registration and commercialization of medical devices;
collaborates with the regulatory staff from other development centers, companies,
government agencies and Product Regulatory Subcommittees to develop harmonized
policies, procedures and work instructions for emerging regulatory topics.
: Master’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 12 years of experience in the offered position or related or Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 14 years of experience in the offered position or related.
SPECIAL SKILLS REQUIREMENTS
: Experience establishing and implementing premarket regulstory strategy. Experience writing and submitting premarket submissions to regulatory agencies. Experience preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses. Experience applying 21 CFR 803, 806 and 820 regulations. Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries. Experience with FDA audits in multiple roles (regulatory representative, back room lead, scribe, etc) and capability to pull data and provide supporting documentation in a timely manner when faced with limited time and resources.
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.
North America-United States-FL-Miami
Danaher - 22 months ago