Director, Regulatory Affairs, LED

Job Description

When 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.com

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.

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