Regulatory Affairs Specialist

Regulatory Affairs Specialist

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.

Pay and Benefits: 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)

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

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