Staff Regulatory Affairs Specialist Job in Miami 33102, Florida Us

Purpose of the position:

The Staff Regulatory Affairs Specialist in Miami, FL plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. The incumbent plans and implements pre-market registration, reporting and compliance activities in accordance with the development center business plans; designs and implements global regulatory compliance programs for product corrective action and/or adverse event reporting; directs ongoing regulatory programs necessary for compliance with global regulations and/or quality systems; and is a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

Responsibilities include, but are not limited to the following:

• Coordinate and prepare regulatory submissions required to obtain registration for new products.
• Coordinate and prepare regulatory submissions for all geographies.
• Develop and implement strategies for earliest possible product licensure, approval, or clearance.
• Participate on project teams and provide regulatory guidance to ensure complete and scientifically sound product submissions.
• Provide guidance and regulatory input to various functional groups as required.
• Interact directly with regulatory authorities, and represent the company on defined matters.
• Serve as liaison between company and the agency for product submissions.
• Participate in adverse event, field corrections and removals and other post marketing activities for products.
• Review and approve clinical and validation protocols and resultant data analyses.
• Complete and maintain all regulatory documentation to system release products.
• Work on complex problems where analysis of situations or data requires an evaluation of complex factors assigned products.
• Exercises judgment within broadly defined practices in developing methods, techniques and evaluation criteria for obtaining results for assigned products.
• Determine methods for new assignments and provide guidance to others on assigned products.
• Take ownership and responsibility for developing and executing regulatory strategy.
• Ability to prioritize tasks and manage multiple project simultaneously, meet deadlines and adjust to changes in workflow and project prioritization.

Required Qualifications and Experience:

• Bachelor’s degree in biological sciences or technical field and 10 years of relevant experience or a Masters degree and 6 years of relevant experience or PhD and 4 years of relevant experience.
• 7 years of regulatory experience in in-vitro diagnostic, medical device, or pharmaceutical industry, hematology and/or flow cytometry is highly desirable.
• Direct experience with PMAs, 510(k)s, Health Canada, and EU IVDD submissions
• Experience working with CBER desirable
• Problem solving, analytical thinking, leadership experience, and strong technical skills.
• Ability to exercise judgment within defined procedures and practices to determine appropriate action
• Ability to develop and track project plans.
• Proven experience monitoring policies, procedures and standards relating to Regulatory Affairs.
• Ability to work with team members to resolve problems and achieve goals
• Experience recommending change.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.

AA/EOE/M/F/D/V

Apply online at: https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetailccid=bupJEdUjsTs=job_REQUISITION_NUMBER =90449

Company Description:

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. Instruments for life science research are used by scientists as they study complex biological problems including the causes of disease, identify new therapies, and test new drugs. Our customers include hospitals, physicians´ offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world.

From complex DNA sequencing to simple diagnostic screening kits, Beckman Coulter is one of the world´s largest companies devoted solely to biomedical testing. The company, based in Brea, California has operations in more than 130 countries, we employ over 11,000 employees including research scientists, engineers, manufacturing associates and other professional and technical staffs. We offer opportunities for every employee to make an impact at Beckman Coulter-and on the health of people worldwide through our products which support advances in patient care. 

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