Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.Discover Impactful Work:The Director of Regulatory Affairs (RA) is responsible for owning the regulatory activities within the Laboratory Equipment Division (LED) business with emphasis on regulatory strategy and the preparation, review and submission of documents for product submissions to support the commercialization of these products. The RA Director is able to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet all required legislations. The leader will develop, mentor, and supervise regulatory professionals within this business area.What Will You Do?
Regulatory lead for the LED business. Partners with business leads to advise and develop regulatory strategy to enable global commercialization for products.
Responsible for providing regulatory mentorship and support to product development teams for strategic design and development, and post-market surveillance and compliance activities
Writes, coordinates, compiles, and submits Regulatory documents to regulatory agencies including FDA, including International Authorities such as Health Canada, NMPA which includes Pre-submission documents, PMA and/or 510k submissions, CE/MDR Technical Files as well as NMPA partners such as UL, CSA or appropriate notified bodies.
Anticipates, reviews and provides interpretation of regulations and standards, as related to the company products and processes. Provide mentorship on Quality System policies and procedures to ensure compliance with FDA 21 CFR, ISO, and applicable Quality System Regulations.
Engages regulators, when vital, in oral and written communications to discuss pending or new submissions, regulatory requirements, address questions, etc.
Serves as RA subject matter authority and keeps current in regard to global regulations, guidance documents, Federal Register notices, and competitor news
Coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
Conduct trainings and/or communicate appropriate materials, as needed, in order to improve team’s knowledge of working in a regulated environment
Promotes continuous improvement and harmonization to drive operational and global Q&RA system efficiencies to meet customer and global regulatory standards
Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Participate in business meetings with existing and prospective external partners
Leads a team of regulatory professionals
May act or delegate the PPRC and/or official correspondent when vital for IVDR/MDR products.
Keys to Success:Education
Minimum requirement of a Bachelor’s degree in life sciences, bio-engineering or related science
Experience
Minimum of 10+ years regulatory experience in Pharmaceuticals, BioPharma, or Medical Devices and a minimum of 5+ years of Medical Device/IVD experience
Validated experience in multiple aspects of RA, including; strategy creation, design control, cGMP/Quality Systems, and import/export requirements
Experience in strategy creation, design and change control, cGMP/Quality Systems, and Product Legislation Compliance requirements
Successful experience in engaging with Regulatory Agencies
Strong demonstration of leadership capabilities required, with experience in influencing diverse, global teams and driving organizational and process changes
Knowledge, Skills, Abilities
Positive demeanor and service-minded approach
Excellent written and verbal communication skills, including presentation skills. Demonstrated ability to communicate clearly, succinctly, and effectively in person, over the phone, and in writing
Comfortable presenting with executive management
Strong interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
Ability to work as a member of a team in a demanding environment with limited supervision
Must possess strong organizational skills, yet able to balance multiple projects concurrently
Knowledge of both quality system and regulatory product compliance requirements; e.g 21 CFR 820, ISO 13485/9001, QMSR, EU MDR, ISO 14971, UL, CSA, NSF, NMPA, Health Canada
We provide competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Thermo 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.