Regulatory Affairs Project Manager; Relo

Regulatory Affairs Project Manager (Relo Available)

Location:

Atlanta, GA (Onsite). Relocation assistance available.

$/yr - $/yr

A medical device company located in Atlanta, Georgia, focused on developing solutions that address cardiac and vascular surgeons’ most complex challenges in treating patients with aortic disease is seeking to add a Regulatory Affairs Project Manager to its team. In this role, the individual provides technical leadership and implements regulatory strategies that support organizational objectives.

• Supports complex technical projects through initiative, critical thinking, and effective decision-making, with the ability to balance competing priorities and escape issues when critical risks arise. Applies project management skills across all assignments.
• Supports cross‑functional technical and strategic initiatives and partners with business teams to improve internal processes. Maintains current knowledge of U.S., EU, and international regulatory landscapes to ensure projects meet organizational plans and expectations.
• Is accountable for executing regulatory strategies and managing global submission activities, including 510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian licenses, and international registrations. This includes amendments, supplements, renewals, annual reports, and responses to requests for additional information.
• Reviews significant product submissions with project stakeholders and negotiates submission issues with regulatory agencies as needed. Ensures timely approvals and market release.
• Provides regulatory support for marketed products, including review of labeling, promotional materials, product changes, site registrations, and inspection/audit support.
• Partners with global and international regulatory teams to support new products and changes to existing products. Works with cross‑functional teams and subject matter experts to address regulatory questions and maintain compliance.
• Maintains advanced‑to‑expert knowledge of worldwide regulatory requirements and builds effective relationships with regulatory agencies and industry leaders.
• Collaborates with Regulatory Affairs colleagues to implement process improvements for regulatory documentation and procedures.
• Works with colleagues to resolve regulatory issues, ensure quality system compliance, and deliver high‑quality outcomes.
• Supports the creation and maintenance of regulatory processes and SOPs and supports site and product compliance. Contributes to quality system programs such as CAPAs, NCRs, audits, PMS, and risk management, leading action items as required.
• Identifies and resolves regulatory compliance issues and develops corrective action plans.
• Provides limited work direction and guidance to peers and supports development of less experienced staff through mentorship and example.

• Writes and reviews pre‑market and post‑market submissions.
• Establishes and maintains a strong internal and external network to support assignment completion.
• Provides effective guidance to functional and cross‑functional partners and maintains strong working relationships with regulatory staff and internal and external customers.

• Bachelor’s degree in science, engineering, or a related field with 5–7 years of experience in regulatory affairs, quality, and/or compliance within the medical device or biologics industry.
• Experience with FDA Class II or III devices and/or EU Class IIa/IIb or III devices.
• Strong analytical, technical writing, communication, organizational, project management, and interpersonal skills.
• Working knowledge of global regulatory affairs, product development, and total product lifecycle processes.
• Ability to understand engineering principles, physiology, and medical device use.
• Demonstrated flexibility, initiative, and ability to lead regulatory projects in a fast‑paced environment.
• Proficiency in Microsoft Office Suite.

• Experience with FDA correspondence, Notified Body interactions, TGA and Health Canada submissions (Class III or IV), and international registrations.
• Experience with cardiovascular devices and/or human tissue products.
• Prior participation on cross‑functional teams.
• Excellent written and verbal communication skills.
• Ability to apply regulatory experience to ensure compliance and effective agency interactions.

• Mid‑Senior level

• Full‑time

• Other

• Staffing and Recruiting

Referrals increase your chances of interviewing at Planet Pharma by 2x