Staff Regulatory Affairs Specialist
The Staff Regulatory Specialist will support the Hematology, Urinalysis, and Flow Cytometry business units ti develop, manage, and integrate Beckman Coulter’s regulatory strategies and programs. As a regulatory process expert to development teams, the incumbent creates and integrates advanced regulatory strategies for global registrations and compliance activities; provides regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for emerging regulatory topics.
EDUCATIONAL REQUIREMENTS: Master’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 7 years of experience in the offered position or related or Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 9 years of experience in the offered position or related.
SPECIAL SKILLS REQUIREMENTS:
Excellent organizational skills and attention to detail. Strong work ethic with an ability to work independently. Possess an ability to read, understand, and summarize technical and scientific information. Ability to interpret and apply regulations to company policies and procedures. Demonstrated ability to review and approve design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling. Pragmatic with strong problem-solving skills. Experience working with cross-functional product development teams to ensure regulatory compliance.
Experience establishing and implementing premarket regulatory 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.
Work with Program Managers and technical staff to determine action items and deliverables Track and report status of regulatory deliverables to Program Managers and leadership.
Work to interpret federal/state/international regulations as they apply to our products, processes and/or procedures, advises on impact of regulations, and devise strategies to compliance. Liaison with external regulatory agencies. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products. Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market company’s products in that geography. Ensure company complies with the local regulatory requirements of the country in which the product is marketed. Prepare the necessary documentation, and secure necessary approvals. Respond to regulatory agency inquiries. Apply and/or write the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity. Manage legalization, Apostille, and notarization process. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
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.
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Job posted: 2020-05-12