Global Regulatory Lead, Medical Devices

• Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities.

• Directs submission related activities by leading the team and motivating the staff to successfully execute regulatory strategies. Makes independent judgments and decisions based on regulations and professional experience. Ensures alignment with Regulatory Management as appropriate.

• Acts as Global Regulatory Lead on the cross functional teams developing and executing regulatory strategies, communicating regulatory requirements, and ensuring these requirements are incorporated into program deliverables.

• Manages the preparation of global registration packages and responses to requests for additional information. Negotiates submission data requirements and deliverable dates with internal technical teams. Author with team members, regulatory submissions for the Infusion Systems infusion pump product portfolio.

• Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products.

• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes changes and present scientific rationale for ease of regulatory agency review.

• Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.

Requirements

• A minimum of seven years of medical device industry experience with a minimum of five years in regulatory affairs with direct experience and authoring 510(k) and/or CE technical files.
• Bachelor’s Degree required in pharmacy, biology, chemistry, pharmacology, engineering or related subject. 2-4 years of managerial experience.
• Direct experience in working with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents.
• RAC Certification preferred.
• Ability to lead scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload for self and others.
• Proven experience of preparing 510(k) submissions and obtaining clearances in their name.
• Good interpersonal skills and strong oral and written communications skills.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members.

🔍 ATS Optimization Keywords
Below are skills and terms extracted directly from this job posting to improve Applicant Tracking System (ATS) visibility. This unique feature helps candidates tailor their applications more effectively — a feature exclusive to Job Tailor job listings.

Hard Skills

• regulatory strategies
• 510(k) submissions
• CE technical files
• regulatory submissions
• global registration packages
• regulatory agency interactions
• scientific rationale
• regulatory compliance
• risk analysis
• project management

Soft Skills

• leadership
• analytical reasoning
• logical reasoning
• prioritization
• interpersonal skills
• oral communication
• written communication
• critical thinking
• contingency planning
• negotiating

Certifications & Qualifications

• RAC Certification