Senior Project Manager, Global Regulatory Intelligence

This is a fully remote position, open to applicants in United States.

📋 Description

• Monitor, collect, analyze, and interpret global regulatory developments, encompassing regulations, guidelines, standards, and legislation.

• Identify, mitigate, and manage regulatory or compliance risks effectively.

• Communicate new and forthcoming regulatory changes and aid in their interpretation.

• Evaluate impacts on business operations and offer actionable insights to internal stakeholders.

• Facilitate internal review and implementation in collaboration with subject matter experts.

• Oversee regulatory intelligence tools, databases, and information resources.

• Maintain proficiency in global regulatory requirements and foster relationships with agency personnel and industry organizations.

• Work alongside functional partners to refresh regulatory and compliance documentation and procedures.

• Serve as a Regulatory Subject Matter Expert, providing strategic guidance.

• Collaborate with quality, clinical, legal, operations, R&D, and other cross-functional teams.

• Lead intricate technical projects while managing competing priorities.

• Educate others on regulatory systems and tools.

• Offer advice on process enhancements and lead assigned improvements to completion.

• Assist with regulatory submissions and track and report on regulatory actions and submissions.

• Engage in inspections, audits, and post-audit corrective actions.

• Maintain and update regulatory processes and Standard Operating Procedures (SOPs).

• Support quality system programs, including Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), audits, Post-Market Surveillance (PMS), and Risk Management.

⛳️ Requirements

• Bachelor's degree in a scientific, engineering, or related discipline.

• At least 4 years of experience in regulatory, quality, and/or compliance within the medical device or biologics sectors.

• Familiarity with FDA Class II or III devices or EU Class IIa/IIb or III devices.

• Experience in interpreting and applying new regulations, legislation, standards, or guidelines.

• Strong skills in analytical thinking, technical writing, communication, organization, project management, time management, and building interpersonal relationships.

• Understanding of global regulatory affairs, product development, and total product lifecycle processes.

• Ability to analyze complex information and convert it into actionable intelligence.

• Proficiency with regulatory intelligence databases, monitoring tools, and standard office software.

• Experience collaborating with cross-functional teams.

• Capability to grasp principles of engineering, physiology, and medical device usage.

• Aptitude for managing and prioritizing multiple projects and responsibilities.

• Demonstrated flexibility, adaptability, initiative, and readiness to lead regulatory projects.

• Project management experience is essential.

• Expertise in the Microsoft Office Suite.

• Preferred: Experience with US FDA, interaction with Notified Bodies, Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices, and/or human tissue.

🏝️ Benefits

• Equal Opportunity Employer.

• Accessibility accommodation available for applicants with disabilities.