Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionDiscover a Unique Opportunity:Join Thermo Fisher Scientific Inc. as a Clinical Trial Reg Affairs Manager specializing in medical devices and diagnostics and make an important impact on a global scale. As part of our outstanding team, you will contribute to our mission of enabling our customers to make the world healthier, cleaner, and safer. At Thermo Fisher Scientific, we provide outstanding resources and support to help our global teams achieve their individual career goals while developing innovative solutions for some of the world's toughest challenges.Are you interested to play a crucial role in the development of novel and innovative medical devices?The Regulatory Affairs Manager develops regulatory strategies and supports product development across a broad range of medical devices, in vitro diagnostics (IVD), and combination products. The role works across the full product lifecycle including strategic development, engagements with regulatory agencies to confirm acceptability of regulatory strategy, facilitating investigational use of products, as well as the preparation of marketing applications.The Regulatory Affairs Manager identifies and communicates potential risks and mitigations associated with regulatory strategies throughout the product lifecycle and develop solutions with other members of regulatory and cross-functional teams.The Regulatory Affairs Manager evaluates changing regulations and guidance, to provide strategic advice, technical expertise, and product development support to internal and external clients.Responsibilities:
Understand and interpret US and global regulatory requirements for medical devices, in vitro diagnostics (IVD), and combination products.
Author pre-submissions, breakthrough device designation requests, study risk determination requests, and 513(g) Requests for Information.
Review nonclinical, analytical and clinical protocols including clinical investigations and performance evaluation plans and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Draft and prepare product technical documentation for submission briefing books and applications, design dossiers, technical files, Summary of Technical Documentation files.
Prepare IDE submissions to support investigational use and provide regulatory support for clinical studies ensuring compliance with Good Clinical Practice.
Review and / or author medical device marketing application submissions including 510(k), de Novo classification, PMA, HDE and lead process through clearance/approval.
Finalize and review regulatory documents and submissions.
Review product labels, labeling, and promotional materials.
Requirements:
Bachelors Degree or equivalent
Solid understanding of global regulatory requirements and regulatory affairs procedures for medical device, IVD, and combination product development, investigational use, and marketing authorization is required.
Experienced with therapeutic medical devices. Experience with neurology devices is a plus.
Proven experience in authoring FDA marketing applications, investigational use applications and pre-submission engagements is required.
Working knowledge of investigational device requirements including 21 CFR Part 812, ISO 14155, ISO 20916, and ICH is required.
Technical writing skills and proficiency at compiling successful submissions for the appropriate audience is required.
Detailed understanding of product requirements related to software verification and validation, cybersecurity, basic safety and performance for medical electrical equipment, biocompatibility (ISO 10993), risk assessment and usability.
Demonstrated project management and communication (written and oral) skills to all levels within the organization and external to the organization.
Excellent judgment, analytical, and decision-making to manage sophisticated projects in parallel and handle rapidly changing priorities.
Demonstrated ability to prioritize competing tasks and deadlines, and coordinate complex information.
Must be self-motivated by working independently and having the ability to take ownership of their responsibilities. Capable of delegating tasks and facilitating the completion of assignments.
Demonstrated analytical thinking to comprehend and analyze an issue, and resolve problem.
Join an organization that values integrity, intensity, innovation, and involvement. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Apply today and start your story at Thermo Fisher Scientific.Thermo Fisher Scientific is an equal opportunity employer and provides reasonable accommodation for job seekers with disabilities. If you require accommodation or assistance during the application process, please contact us at 1-855-471-2255. Please include your contact information and specific details about your required accommodation.Apply today at 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.