Regulatory Affairs Coordinator

Description

Prepare, update, and maintain regulatory documentation to support global submissions, including FDA device listings, Health Canada Medical Device Licenses, EU technical documentation, and other market registrations.

Review and approve product labeling, CERs, PMS Plans, PSURs, packaging, and Instructions for Use (IFUs) for regulatory compliance across key markets.

Maintain regulatory databases such as FDA FURLS/GUDID, Health Canada listings, and EUDAMED, ensuring timely and accurate updates.

Support change control and product lifecycle management activities by providing regulatory impact assessments and guidance.

Maintain organized and inspection-ready regulatory files, correspondence, and submission archives.

Collaborate with Quality, R&D, Marketing, and Supply Chain to ensure regulatory alignment on product changes, risk documentation, and labeling content.

All other duties as assigned.

Additional Skills & Qualifications

BS Degree in Life Science

0-3 years of experience in Regulatory Affairs or a related function in the device or life science industry

Experience with regulatory submissions preferred but not required

Experience with US FDA, EU MDR and Health Canada preferred

Job Type & Location

This is a Contract to Hire position based out of Noblesville, IN.

Pay and Benefits

The pay range for this position is $25.00 - $40.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of Noblesville, IN.

Application Deadline

This position is anticipated to close on Nov 25, 2026.

Workplace Type

This is a fully onsite position in Noblesville,IN.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.