Senior Regulatory & Quality Compliance Specialist

Job Description

Job Description

Senior Regulatory & Quality Compliance Specialist

Company: Rad Source Technologies, Inc.

Location: Buford, GA (on-site)

Department: Quality / Regulatory

Reports to: Director / Head of Quality & Regulatory Affairs

Experience: 10+ years required

 

About Us

We design and manufacture advanced X-ray and irradiation technology for medical, research, and industrial markets. Our systems are used worldwide, and quality and regulatory compliance are central to everything we ship. We’re looking for a seasoned regulatory and quality professional to serve as a senior pillar of our quality function — keeping us compliant and audit-ready, and making sure our quality system is understood and followed across the entire company.

 

The Role

This is a senior, hands-on position for a deeply experienced regulatory and quality professional. You’ll report to the Head of Quality & Regulatory Affairs and start as the go-to expert and driving force behind our regulatory compliance and quality system — owning day-to-day regulatory compliance, contributing to our QMS policies and procedures, and ensuring every department actually adheres to the system in practice.

 

This role is designed with a clear growth path. We’re looking for someone with the experience, judgment, and leadership capability to grow into full ownership of the quality function over time. The ideal candidate can step in as a senior contributor today and demonstrate the readiness to lead the entire department down the road. If you know the regulations cold, work well across teams, and want a role where strong performance opens the door to leadership, this is built for you.

 

What You’ll Do

• Serve as the company’s subject-matter expert on regulatory compliance, ensuring ongoing conformance with FDA 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and notified body / EU MDR requirements.
• Develop, review, and maintain QMS policies, procedures, and work instructions, keeping them current, practical, and aligned with applicable regulations.
• Drive company-wide adherence to the QMS — partnering with every department to ensure procedures are understood, followed, and consistently applied in daily operations.
• Support FDA inspections, notified body audits, MDSAP audits, and ISO 13485 certification audits — preparing documentation, participating in audits, and helping coordinate timely, effective responses.
• Plan and conduct internal audits, monitor compliance, and escalate gaps and risks to Quality & Regulatory leadership.
• Manage CAPA, nonconformances, and audit-finding follow-up through to closure, ensuring root causes are addressed and corrective actions are effective.
• Support document control, design controls, risk management (ISO 14971), and training programs, and reinforce a culture of compliance across the organization.
• Provide regulatory guidance to engineering, manufacturing, and operations teams, and support regulatory submissions and maintenance as needed.

 

What You Bring

• Minimum 10 years of regulatory and quality experience in the medical device industry.
• Deep, demonstrated knowledge of FDA 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and notified body / EU MDR requirements — this is the heart of the role.
• Hands-on experience supporting FDA inspections, MDSAP audits, and notified body audits, including preparation, hosting, and response.
• Strong command of QMS policy and procedure development, internal auditing, CAPA, design controls, and risk management.
• •Proven ability to drive cross-functional adherence to a quality system — influencing and holding other departments accountable without direct authority over them.
• Excellent communication skills and a collaborative, ownership-minded approach.
• The leadership capability and ambition to grow into full ownership of the quality function — comfortable today as a senior contributor, with a clear trajectory toward leading the department.
• Bachelor’s degree in engineering, life sciences, or a related field.

 

Nice to Have

• Experience with radiation-emitting / electronic products and the associated FDA requirements (21 CFR 1020, electronic product radiation control).
• Certifications such as ASQ CQA / CMQ-OE, RAC (Regulatory Affairs Certification), ISO 13485 Lead Auditor, or MDSAP Auditor.
• Experience with regulatory submissions (510(k), EU MDR technical documentation) and international product registrations.
• Background in a small-to-mid-size manufacturing environment where you wear multiple hats.

 

Why Join Us

You’ll be a senior, trusted expert in a quality function that genuinely matters to the business — with real influence over how we stay compliant and how we operate, and direct access to leadership. Just as important, this is a role with room to grow: we want this position to be filled by someone capable of eventually taking over the quality function entirely. Prove yourself here and the path to leading the department is open. This isn’t a seat in a large bureaucracy; your expertise will shape the company every day.

 

Compensation:

• Compensation is competitive and will be based on the candidate's skills, experience, and qualifications.

 

Benefits:

• Monthly Benefit Allowance awarded to all employees.
• Comprehensive Benefits Package
• 401(k) Match – 100% up to 5% / fully vested immediately
• PTO and Holiday Pay
• Opportunities for growth
• Monday - Friday

 

Rad Source Technologies, Inc. is an equal opportunity employer where employment is based upon personal capabilities and qualifications without discrimination because of race, color, religion, gender, age, national origin, disability, veteran status, or any other protected characteristic as established by law.

 

Disclaimer: This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.

Company Description

Rad Source was founded in 1997 for the purpose of creating non-gamma irradiation alternatives. Even prior to the more recent security issues associated with radioactive gamma sources, the company’s vision was to solve environmental disposal and related practical issues associated with “hot” source equipment.

Based on that, we introduced our first products in 1999 incorporating x-ray technology including the first FDA cleared x-ray blood irradiator as well as our laboratory research x-ray irradiator, the RS 2000.

Since then, we’ve continued expanding our capabilities and adding to our proprietary x-ray based irradiation technology, developing proprietary x-ray sources and new equipment. We are a global enterprise and our equipment resides in major pharmaceutical labs, healthcare institutions and renowned universities around the world. We are based in Buford, Georgia, USA where our highly qualified and dedicated staff continues to develop our technology, design and produce our equipment.

Company Description

Rad Source was founded in 1997 for the purpose of creating non-gamma irradiation alternatives. Even prior to the more recent security issues associated with radioactive gamma sources, the company’s vision was to solve environmental disposal and related practical issues associated with “hot” source equipment.\r\n\r\nBased on that, we introduced our first products in 1999 incorporating x-ray technology including the first FDA cleared x-ray blood irradiator as well as our laboratory research x-ray irradiator, the RS 2000.\r\n\r\nSince then, we’ve continued expanding our capabilities and adding to our proprietary x-ray based irradiation technology, developing proprietary x-ray sources and new equipment. We are a global enterprise and our equipment resides in major pharmaceutical labs, healthcare institutions and renowned universities around the world. We are based in Buford, Georgia, USA where our highly qualified and dedicated staff continues to develop our technology, design and produce our equipment.