Director Regulatory Affairs LED
Director Regulatory Affairs LED
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
When youre part of the team at Thermo Fisher Scientific youll do important work. And youll 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 postmarket 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 Presubmission 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 teams 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 Bachelors degree in life sciences bioengineering 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 serviceminded 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 100000 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!
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.
Accessibility/Disability Access
Job 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*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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Required Experience:
Director
Employment Type
Full-Time
