Regulatory Affairs Specialist

Job Description

Job Description

We are looking to hire a Regulatory Affairs Specialist to work for a well established manufacture in the Dallas Fort-Worth area. The company develops and manufactures specialized healthcare products, with a focus on quality, innovation and improving patient care.

ESSENTIAL DUTIES:

1.Prepare and submit regulatory documents to appropriate agencies for registrations.

2.Support compliance with local, national, and international regulations.

3.Support internal audits and external audits.

4.Keep current with changes in relevant regulations and standards.

5.Compose CAPAs related to compliance.

6.Support Manufacturing, Product Development, Marketing, and Sales.

7.Support international partners with documentation for registration of products.

8.Editing and/or drafting policies, procedures, work instructions, specifications, technical documentation, records.

9.Assist with product complaints.

10.Assist work with clinical staff to generate PMS, CER, PSUR, PMCF reports.

EDUCATION & EXPERIENCE

1.Bachelors degree in a related field (e.g., Scientific Discipline, Engineering, pre-Law).

2.Minimum of 2 years of experience in quality assurance, regulatory affairs, or a related role for medical devices.

3.Examples of relevant regulatory requirements and quality standards - ISO 13485, FDA QMSR and Title 21 Subchapter H, EU MDR Regulations, ISO 14001, ISO 14971, etc.

4.Strong attention to detail and excellent organizational skills.

5.Effective communication and interpersonal skills.

6.Ability to work independently and as part of a team.

7.Proficiency in Microsoft Office Suite and relevant quality management software.

8.Technical writing is preferred.

Job Type & Location

This is a Contract position based out of Fort Worth, TX.

The pay range for this position is $30.00 - $45.00/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)

This is a fully onsite position in Fort Worth,TX.

This position is anticipated to close on Oct 19, 2026.

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.