Regulatory Affairs Specialist

Arrotek Medical Ltd; Garland (TX); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Theragenics, the parent company behind Arrotek, seeks a Regulatory Affairs Specialist to drive global regulatory compliance and submissions for medical devices across domestic and international markets.

You will collaborate with Quality, Engineering, Operations, and Documentation teams to manage FDA 21 CFR 820, ISO 13485, EU MDR, and regulatory filings, ensuring timely approvals and ongoing compliance in a hybrid role.

Qualifications

• Bachelor’s degree in a science or engineering field is required.
• 3–5 years of experience in regulated environments (clinical research or medical manufacturing).
• Experience with FDA, EU MDR, and MDSAP.
• Bilingual in English and Spanish (written and verbal) required.

Responsibilities

• Coordinate preparation and submission of regulatory documents and product registrations for FDA/intl markets.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and MDSAP.
• Support internal audits, supplier and regulatory agency audits as needed.
• Provide regulatory guidance to cross-functional teams and communicate with notified bodies.

Skills

Bilingual English/Spanish

Education

Bachelor’s degree in science or engineering

Advanced degree (preferred)

Job description

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, blood vessel procedures, and surgical applications. The company is based in Atlanta, Georgia, and has facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that enhance lives.

Note: This is a hybrid position.

Role Summary

As a Regulatory Affairs Specialist, you’ll play a pivotal role in driving global regulatory compliance and product submissions, collaborating with cross-functional teams to deliver cutting-edge solutions in medical device regulatory affairs across domestic and international markets.

Key Responsibilities

• Regulatory Compliance: Partner with Quality, Engineering, Operations, and Document Control to ensure business compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR, MDSAP, and applicable international regulations.
• Regulatory Submissions: Coordinate the preparation, assembly, and submission of 510(k)s, Technical Files, Letters to File, Product Registrations, and international market registrations to obtain approvals for product development, clinical trials, and marketing authorizations.
• Documentation & Audits: Prepare, review, and submit regulatory documents, maintain up-to-date regulatory files, conduct internal audits, and support customer and regulatory agency audits as needed.
• Global Strategy & Guidance: Stay abreast of evolving global regulatory requirements, provide regulatory guidance to project teams, and facilitate communication between internal stakeholders, notified bodies, and regulatory authorities.
• QMS Support: Offer support in Quality Management System (QMS) operations, including surveillance, reporting, and label approvals as necessitated.

Qualifications & Skills

Required Qualifications

• Bachelor’s degree in a science or engineering field (such as biology, chemistry, or pharmacy).
• 3 to 5 years of working experience in a regulated field like clinical research or medical manufacturing.
• Experience working with international manufacturing locations.
• Direct working experience with FDA regulations, EU MDR, and MDSAP.
• Bilingual fluency in both English and Spanish (written and verbal).

Preferred Qualifications

• Advanced degree in a related science or engineering field.
• Experience with Class II and/or Class III medical devices.
• Experience supporting manufacturing operations in Latin America.
• Regulatory Affairs Certification (RAC) and/or Regulatory Affairs Professionals Society (RAPS) membership.

Success Measures

Within The First 12 Months, The Successful Candidate Will

• Significantly progress EU MDR submissions.
• Identify post-submission continuous improvement actions.
• Maintain successful FDA, ISO, and customer audit outcomes with no critical findings.

Why Join Us

• Purpose-driven work: Directly contribute to the approval and delivery of life-changing medical technologies.
• Innovative projects: Engage with complex global markets, EU MDR initiatives, and class-leading medical devices.
• Collaborative culture: Work side-by-side with cross-functional teams spanning quality, engineering, and international operations.
• Career growth: Expand your regulatory expertise across multiple global jurisdictions and regulatory frameworks.
• Competitive benefits: Enjoy a comprehensive total rewards package designed to support you and your family.