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Director, Global Regulatory and Clinical Affairsn nn location Remote / Field, California, US Job ID: 154991BR nn nnThermo Fisher Scientific Inc.
is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit www.thermofisher.com.nn nn How will you make an impact?
nn nnThe Sr.
Director of Global Regulatory and Clinical Affairs will be responsible for the Genetic Sciences Division (GSD), driving regulatory and clinical strategies to support the business.nn nnThe incumbent will be part of the Thermo Fisher Scientific GSD Quality and Regulatory team based in the U.S.
and will serve as an active leader of Regulatory and Clinical Affairs supporting the growing GSD businesses.nn nn What will you do?
nn nnGSD focuses on various diagnostics solutions including test kits, reagents, instruments, software and associated products.
Our products empower healthcare providers to make medical decisions, faster, more accurate and more cost effective for patients.
What we do matters because our work has a direct impact on people’s lives and we take that responsibility seriously.nn nn Key Responsibilities: nn Establish and manage all aspects of regulatory strategy across GSD.
Ensure that Regulatory Affairs (RA) teams globally, are accountable for delivering on agreed strategies and tactics.
Establishing organizational structures and policies that are uniformly deployed across GSD.
Lead, motivate and teach associates in the development of a customer-focused culture of quality that is based on industry-leading practices.
Oversee the process that ensures the appropriate licensing, marketing and legal compliance of all appropriate diagnostics and medical device products globally.
Advise the regulatory teams on the optimal regulatory strategies, submissions and approval pathways.
Partner with R&D, marketing, manufacturing and legal, leadership within the division.
Hold the businesses accountable for delivering on agreed timelines and global commercialization approaches.
Remain well-versed in evolving global regulatory policies and advise business units internally on anticipated changes, net business effect and appropriate strategies/processes to appropriately address.
Perform as the subject matter expert (SME) and resource on related regulations and standards, both US and foreign.
Assist with the development of policies and provide training and other compliance assistance in these areas of responsibility.
Oversee the process which ensures that products comply with the regulations of all applicable regulatory agencies where they are marketed.
Provide constant updates on changing international legislation, guidelines and customer practices.
Develop clear processes for regulatory approvals, working with commercial teams to define ASR vs CLIA vs EU vs FDA based approaches and related timelines as well as potential reimbursement ramifications.
Manage regulator recalls and MDR reporting, interact with government agencies on same.
Develop processes and set timelines for license variations and renewal approvals.
Oversee regulatory communications with marketing to ensure appropriate approval of commercial literature and language.
nn Qualifications: nn Minimum 12+ years of regulatory affairs experience that includes FDA as well as global health authority interaction.
Prior experience leading and building a global Regulatory function Experienced in leading fundamental change or process improvement on a global basis moving toward a global shared services model.
Hands-on experience with classification of devices; listing, registration, and approval of devices; adverse event reporting, and recalls required.
Have expertise with the US Food and Drug Administration (FDA), European Medicines Agency, IVDD/CE, JPAL, CFDA, SFDA regulatory processes and expectations, and be able to interact with these agencies as standards evolve and new products open up questions on approach and regulatory standards.
Experience interpreting and working under the regulations governing the approval of new products and the expectations and processes employed by the FDA and EU agencies, CE mark, 510k, PMA, technical files and design dossier.
Additional experience with similar ex-US (e.g., Canada, China, Japan, etc.) regulations ideal.
Possess IVD technical expertise and regulatory knowledge to drive products through the approval and commercialization phases.
Technically savvy using IT databases and familiarity with commercial software Ability to drive results in a matrix organization, especially having representatives from different cultures come together, embracing diversity Strong demonstration of leadership capabilities with experience in leading programs and projects nn Travel Requirement nn 25-40% regional and international travel is expected nnAt Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell.
Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.nn nnThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.nn nn To access this job later or share with a friend, please enter Name and Email Address below.
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n nn How would you rate your experience popup nn nn Thermo Fisher Scientific Inc.
is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit www.thermofisher.com .
nn nn Thermo Fisher Scientific is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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