Regulatory Affairs Specialist

Job Description

Job Description

We’re Hiring: Regulatory Affairs Lead (Medical Devices)

Location: Memphis, TN preferred (Open to Remote — please specify your location and time zone on your resume)

Role Level: Lead / Senior Specialist

Are you an experienced Regulatory Affairs professional looking to drive global strategy and lead critical submissions for cutting-edge medical devices? We are seeking a Regulatory Affairs Lead to take full ownership of global regulatory strategies, submission execution, and agency compliance for both new and modified products.

Working independently and cross-functionally, you will serve as the primary RA representative on project teams to ensure global launch timelines and compliance standards are met seamlessly.

• Global Submissions: Prepare and review US 510(k) and EU technical documentation; support regional teams on international regulatory submissions.

• Strategy & Project Leadership: Serve as independent RA lead on project teams to develop regulatory strategies, testing requirements, and market expansion plans to hit global product launch targets.

• Audit & Agency Engagement: Plan, lead, and support internal and regulatory agency audits while leading direct engagements with regulatory authorities.

• Change Management & SOPs: Conduct regulatory change assessments (design, labeling, manufacturing) to maintain domestic and international compliance; develop and maintain company SOPs.

• Labeling & Technical Guidance: Review product labeling for regulatory compliance and provide technical guidance, training, and mentorship to RA team members and cross-functional partners.

• Deep expertise in global regulatory requirements, guidance documents, standards, and medical device terminology.

• Proven experience preparing US 510(k) and EU technical documentation.

• strong leadership and project management skills with the ability to work independently.

• Excellent cross-functional communication and experience mentoring team members.

Interested in making a global impact? Apply today or message us directly with your resume (don't forget to include your current location and time zone!).

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Responsibilities

Location: Memphis preferred (Open to Remote; please state location & time zone on resume)

Key Responsibilities:  

• Global Submissions: Prepare and review US 510(k), EU technical documentation, and support regional teams on international submissions for new and modified devices.

• Regulatory Strategy & Project Leadership: Serve as independent RA lead on project teams to establish regulatory strategies, testing requirements, and submission approvals for timely global launches. Lead regulatory-driven projects as directed.

• Market Expansion & Compliance: Execute regulatory strategies to support market expansion. Maintain up-to-date knowledge of global regulations, standards, medical terminology, and device requirements.

• Audits & Agency Engagement: Plan, lead, and support internal and regulatory agency audits; lead direct engagements with regulatory authorities.

• Change Management & SOPs: Oversee regulatory change assessments (design, labeling, manufacturing) to ensure domestic/international compliance. Develop and maintain company SOPs.

• Review & Guidance: Review product labeling for regulatory compliance. Provide technical guidance, training, and mentoring to RA colleagues and cross-functional teams.

• Regulatory reporting
• Regulatory Compliance - Other (1 year of experience is required)
• EU technical documentation

Qualifications
• Years of experience: 3 years
• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on ziprecruiter.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.