Title:  Principal Regulatory Affairs Project Manager, Medical Devices

Job Summary

• The Principal Regulatory Affairs Project Manager is responsible for leading complex, high‑visibility regulatory programs across West’s portfolio of medical devices, combination products, and packaging/containment systems. This includes driving regulatory strategies, execution, and compliance across global markets.
• In this role, you will collaborate with and provide project management leadership to cross-functional teams to support global clinical and commercial regulatory initiatives, including the planning and submission of high-impact regulatory filings such as Premarket Notifications, EU MDR Technical Documentation, and Master Files (DMF/MAF) that support pharmaceutical partners’ INDs, NDAs, ANDAs, BLAs, and CTAs.
• This role requires strong strategic thinking, the ability to manage competing priorities, and the leadership skills necessary to drive decision‑making across a complex, matrixed environment.

Essential Duties and Responsibilities

• With a high degree of autonomy, lead cross-functional regulatory project teams in the development and execution of global regulatory strategies across the product lifecycle, ensuring alignment with business objectives and evolving regulatory requirements.
• Drive end-to-end regulatory project execution for high-impact programs, from early development through post-market activities, ensuring timely delivery of key milestones, proactive risk management, and strategic decision-making.
• Direct the preparation and submission of complex regulatory dossiers, including initial submissions, amendments, and responses to information requests. Ensure submissions meet quality standards and regulatory expectations. Support submission authoring and reviewing as needed.
• Anticipate and manage regulatory risks for all business priorities, developing and implementing robust mitigation strategies. Lead resolution of complex regulatory issues and ensure timely escalation and closure.
• Provide technical and strategic input on global regulatory plans, change assessments and agency responses.
• Work closely with R&D, quality assurance, clinical affairs, and manufacturing teams to ensure regulatory strategy and considerations are integrated into product development and lifecycle management.
• Lead interactions with external customers, partners and regulatory agencies on pre-submissions, change notifications, audits and information request responses, as required, to fulfill business objectives.
• Drive continuous improvement initiatives within the regulatory function, including the development and implementation of advanced project management tools, performance dashboards, and knowledge-sharing platforms.
• Optimize RA databases for information requests, submissions and integrate additional capabilities for trend analysis and data-driven insights.
• Proactively maintain and interpret current international regulations, guidelines, and policies relevant to West’s products and services and provide guidance to cross-functional teams.

Education

• Bachelor's or Master’s degree in science, engineering, or related discipline

Work Experience

• Bachelors Degree with minimum 5 years experience or Master’s Degree with minimum 3 years experience
• Experience in the area of development, scale-up and registration of regulated medical devices and combination products.
• Proficiency in using project management software and regulatory tools.
• Excellent interpersonal, communication, and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
• Strong leadership skills with team management and decision-making abilities.
• Self-motivated, proactive, and able to work independently in fast-paced environments.

Preferred Knowledge, Skills and Abilities

• Proven track record of successful regulatory submissions and interactions with regulatory authorities.
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical and medical device operations (e.g., manufacturing, process development, analytical, quality assurance). 
• Strong analytical, critical thinking and problem-solving skills.
• Experience in regulated combination product, medical device development, registration of class I and class II medical devices, and profound knowledge of industry-specific regulations and standards.
• Exceptional project management skills, including planning, execution, and budget management.
• Fundamental knowledge of Quality Management System (QMS) requirements, State-of-art standards (ISO 13485, ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements.  
• Experience in medical device life-cycle Management, including change controls, device complaint investigations, CAPAs, and post-market surveillance.
• Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification

Physical and Mental Requirements

• Ability to comprehend principles of math, science, engineering, and medical device use
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents
• Ability to review, collate, describe, and summarize scientific and technical data
• Ability to organize complex information and combine pieces of information to form general rules or conclusions
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures
• Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
• Ability to verbally communicate ideas and issues effectively to other team members and management
• Ability to write and record data and information as required by procedures

Travel Requirements

Must be able to travel up to 10% of the time