Regulatory Affairs Project Manager

Role Overview

• Collaborate with regulatory team members, cross-functional teams and regulatory bodies to plan and schedule regulatory submissions
• Create and manage project plans, when needed, for regulatory projects using input from stakeholders
• Manage/lead regulatory-driven projects and ensure timely receipt of submission supporting documents from cross-functional teams for a timely submission
• May support preparation, review and/or approval of global regulatory submissions, including US and EU, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices
• Work as the RA lead and SME on project teams independently to develop regulatory strategies, testing requirements and other documentation to ensure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets
• Regularly communicate with Business stakeholders on regulatory approval timeframes
• Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology
• Plan, lead and support for internal and Regulatory agency audits, as needed
• Lead and direct engagement with regulatory authorities as required
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams and act as SME for colleagues with less experience
• Other activities as assigned

Requirements

• Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
• RAPS Certification or RA Master’s degree a plus
• PMP Certification a plus
• 8+ years experience in Regulatory Affairs
• 5+ years experience with successful submissions or 2+ years Project Management experience
• Demonstrated experience with high risk classification devices (Class II & Class III)
• Knowledge and practical application of medical device regulations (ISO, GMP, FDA, CE, EU MDR) and design controls
• Experience with internal/External Audits, Quality Systems expertise and clinical study experience beneficial
• Experience working with large cross functional teams and diverse groups
• Processes and Product Lifecycle Management Systems experience is required
• Travel Requirements: <15%

Tech Stack

• PMP

Benefits

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Purchase Plan
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Medical
• Dental
• Vision
• Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Discounts on fitness clubs
• Travel and more!