Planet Pharma · 1 day ago
Regulatory Affairs Project Manager (Relo Available)
Atlanta, GA
Full-time
Onsite
Senior Level
$120K/yr - $140K/yr
5+ years expPlanet Pharma is a medical device company located in Atlanta, Georgia, focused on developing solutions for cardiac and vascular surgeons. They are seeking a Regulatory Affairs Project Manager who will provide technical leadership and implement regulatory strategies to ensure compliance and obtain regulatory approvals for medical devices.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Katelyn Evans
Responsibilities
Supports complex technical projects through initiative, critical thinking, and effective decision-making, with the ability to balance competing priorities and escalate 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
Qualification
Required
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
Preferred
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
Benefits
Salary + Bonus and Equity
Relocation Assistance Available
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase