Regulatory Affairs Specialist

Job Description

Job Description

Our client, a well-established medical device manufacturer in the Dallas-Fort Worth area, is seeking to hire a Regulatory Affairs Specialist immediately to prepare and submit regulatory documentation for medical devices, ensuring compliance with local, national, and international regulations. This role supports audits, quality system activities, and cross-functional teams, while monitoring evolving regulatory requirements and contributing to continuous improvement of the quality and regulatory systems.

Responsibilities

• Prepare, compile, and submit regulatory documents to appropriate regulatory agencies for product registrations.
• Support compliance with local, national, and international regulations governing medical devices.
• Support planning, execution, and follow-up of internal and external audits.
• Stay current with changes in relevant regulations, standards, and guidance documents, and communicate their impact to stakeholders.
• Compose and manage corrective and preventive actions (CAPAs) related to regulatory and quality compliance.
• Provide regulatory support to Manufacturing, Product Development, Marketing, and Sales teams to ensure compliant processes and product claims.
• Support international partners by providing documentation and guidance needed for registration of products in global markets.
• Draft, edit, and maintain policies, procedures, work instructions, specifications, technical documentation, and records to ensure regulatory and quality compliance.
• Assist in the intake, evaluation, and investigation of product complaints in collaboration with quality and clinical teams.
• Collaborate with clinical staff to generate and maintain Post-Market Surveillance (PMS), Clinical Evaluation Reports (CER), Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-up (PMCF) reports.
• Monitor applicable laws, regulations, standards, marketplace trends, and industry practices for their impact on the organizations regulatory and quality systems.
• Prepare gap analyses comparing existing processes and documentation to regulatory and standard requirements, and recommend improvements.
• Communicate with leadership and external consultants to help develop and refine regulatory strategies for products and markets.
• Perform other related regulatory and quality duties as assigned to support departmental and organizational goals.

Essential Skills

• Bachelors degree in a related field such as a scientific discipline, engineering, or pre-law.
• Minimum of 2 years of experience in quality assurance, regulatory affairs, or a related role within the medical device industry.
• Experience with regulatory submissions for medical devices, including 510(k) submissions.
• Knowledge of relevant regulatory requirements and quality standards, including FDA Quality Management System Regulation (QMSR) and Title 21 Subchapter H.
• Familiarity with EU Medical Device Regulation (EU MDR) and related international standards such as ISO-based quality management standards.
• Strong attention to detail with a high level of accuracy in documentation and recordkeeping.
• Excellent organizational skills with the ability to manage multiple tasks and deadlines.
• Effective verbal and written communication skills, with the ability to convey complex regulatory information clearly.
• Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams and external partners.
• Ability to work independently with minimal supervision as well as collaboratively within a team environment.
• Proficiency in Microsoft Office Suite and relevant quality management or regulatory software tools.

Additional Skills & Qualifications

• 23 years of medical device experience preferred, with up to 5 years in regulatory affairs or quality roles considered advantageous.
• Hands-on experience preparing or supporting 510(k) submissions is highly desirable.
• Experience working with international regulatory bodies and supporting global product registrations.
• Experience drafting and editing technical and regulatory documents; technical writing experience is preferred.
• Demonstrated ability to conduct gap analyses and translate findings into actionable improvements.
• Experience supporting audits and interacting with regulators, notified bodies, or external auditors.
• Ability to interpret and apply evolving regulatory requirements and standards to existing products and processes.

Work Environment

The role operates in a professional office and regulated manufacturing environment focused on medical device quality and compliance. You will work closely with cross-functional teams such as Manufacturing, Product Development, Marketing, Sales, and Clinical staff, as well as external consultants and international partners. Standard office productivity tools, including Microsoft Office Suite and quality management or regulatory software, are used routinely. The position offers a hybrid element with remote work on Fridays, while other days are typically on-site, supporting collaboration, audits, and access to technical documentation and systems.

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

The pay range for this position is $95000.00 - $110000.00/yr.

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.

401k, benefits, dental medical and vision

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

This position is anticipated to close on Oct 28, 2026.

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

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.