Back to Jobs search

Regulatory Affairs Manager (Transplant Diagnostics)

ThermoFisher Scientific • Detroit, MI • 1h ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

As a Regulatory Affairs Manager you'll provide strategic guidance on regulatory pathways, manage submissions, and serve as a subject matter expert on various regulations across multiple jurisdictions. Working closely with cross-functional teams, you'll help develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities. This position offers excellent opportunities for growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.

REQUIREMENTS:

Bachelor's Degree plus 5 years of experience in regulatory affairs in IVD/medical device industry

Preferred Fields of Study: Biology, Chemistry, Bioengineering, or related scientific field

Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, TGA, PMDA, MFDS and other international agencies)

Experience preparing and managing regulatory submissions (510(k), PMA, CE marking, technical documentation)

Strong knowledge of quality management systems (ISO 13485, GMP, QSR)

Demonstrated success in regulatory strategy development and implementation

Experience leading regulatory aspects of product development teams

Knowledge, Skills, Abilities

Excellent project management and organizational skills

Strong analytical and problem-solving abilities

Outstanding written and verbal communication skills

Ability to interpret and communicate complex regulatory requirements

Experience with risk management and post-market surveillance activities

Proficiency in reviewing technical documentation and product labeling

Ability to work effectively in a matrix organization

Strong interpersonal skills and ability to build consensus

Willingness to travel (10-15% typically)

Ability to adapt to evolving regulatory landscape

Proficiency with standard office software and regulatory documentation systems

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

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.

Similar Jobs

Registered Nurse, Contact Center

Hospice of Michigan • Southfield, MI • 18min ago

Hospital & Medical

Job Summary: The Registered Nurse (RN), Contact Center meets all requirements of a NorthStar Care Community RN and provides professional nursing services or supervises the provision of nursing services to hospice patient...

18min ago

Go to Apply

Registered Nurse, Contact Center

Hospice of Michigan • Southfield, MI • 18min ago

Hospital & Medical

18min ago

Go to Apply

Registered Nurse, Contact Center

Hospice of Michigan • Southfield, MI • 20min ago

Hospital & Medical

West Team | CA RN License Required Job Summary: The Registered Nurse (RN), Contact Center meets all requirements of a NorthStar Care Community RN and provides professional nursing services or supervises the provision of...

20min ago

Go to Apply

Registered Nurse (RN) Supervisor

Ciena Healthcare Management • Novi, MI • 22min ago

Hospital & Medical

Afternoon Supervisor $10,000 sign on bonus! Paid out quarterly after 90 days. Are you an experienced RN with a passion for leading and teaching other skilled nursing staff? The RN Shift Supervisor provides, plans, coordi...

22min ago

Go to Apply

Registered Nurse

Hospice of Michigan • Southfield, MI • 22min ago

Hospital & Medical

Job Summary: Provides professional nursing services or supervises the provision of nursing services to hospice patients in accordance with accepted standards of practice and organizational guidelines. May perform nursing...

22min ago

Go to Apply

Registered Nurse- Critical Care

Veterans Affairs, Veterans Health Administration • Detroit, MI • 2h ago

Hospital & Medical

Summary This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP applica...

2h ago

Go to Apply

Afternoon Part Time EVS/ Medical Cleaner Mesa 3 Days

CORPORATE CLEANING GROUP EAST VALLEY • Livonia, MI • 7h ago

Hospital & Medical

This job was posted by https://www.azjobconnection.gov : For more information, please see: https://www.azjobconnection.gov/jobs/7457604 Project @types: Medical Facilities and Small Surgery Rooms Cleaning duties include:...

7h ago

Go to Apply

Physician (Chief of Staff)

Veterans Affairs, Veterans Health Administration • Detroit, MI • 21h ago

Hospital & Medical

Summary The John D. Dingell VA Medical Center is recruiting for a Chief of Staff (COS) position. The COS is responsible for the management and operation of all clinical programs and services offered in the medical center...

21h ago

Go to Apply

Medical Assistant

City of Detroit • Detroit, MI • 1d ago

Hospital & Medical

Medical Assistant Print ( https://www.governmentjobs.com/careers/detroit/jobs/newprint/5343792 ) Apply ? Medical Assistant Salary $40,017.00 - $50,416.00 Annually Location 100 Mack Avenue, MI Job Type Certified-Regular C...

1d ago

Go to Apply

Pharmacy Operations Manager

Walgreens • Royal Oak, MI • 1d ago

Hospital & Medical

Job Description: Where state and federal laws/regulations allow, accountable for performing day-to-day non-clinical pharmacy operations, administrative activities; Ensures efficient pharmacy workflow and a positive patie...

1d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)