About the position

The Senior Specialist, Regulatory Project Management is responsible for leading regulatory project execution for West’s global portfolio of medical devices, combination products, software-enabled devices/SaMDs, and packaging components. This role partners with the Regulatory Affairs Lead, Cross-functional SMEs, and external stakeholders to drive regulatory deliverables across development, submission, approval, and post-market lifecycle phases. The successful candidate will bring a strong combination of medical device technical understanding, knowledge of global regulatory frameworks, and project management capability to support timely, compliant regulatory submissions and lifecycle activities. The role supports FDA premarket submissions (510(k)), EU MDR Technical Documentation, Master Files (DMF/MAF), change notifications, information request responses, post-approval commitments, and post-market regulatory deliverables.

Responsibilities

• As Regulatory Project Management, lead execution for assigned medical device, combination product, SaMD/software-enabled device, and packaging component programs across the product lifecycle.
• Develop and manage integrated regulatory project plans, timelines, dashboards, risk/issue logs, decision trackers, and escalation pathways to support timely execution of deliverables.
• Monitor project milestones, dependencies, resource needs, and risks; proactively escalate issues to leadership with recommended mitigation actions.
• Coordinate the preparation, review, approval, and submission of global regulatory filings, information request responses, change notifications, and post-market regulatory reports.
• Partner with Regulatory Affairs Leads and cross-functional subject matter experts to align regulatory strategy, technical deliverables, submission readiness, and lifecycle planning.
• Apply working knowledge of medical device design controls, risk management, verification and validation, usability/human factors, software documentation where applicable, labeling, and post-market requirements to identify technical or regulatory gaps.
• Support interactions with health authorities, notified bodies, pharmaceutical partners, and other external stakeholders by coordinating documentation, responses, commitments, and follow-up actions.
• Contribute to the continuous improvement of Regulatory Project Management tools, templates, procedures, metrics, and best practices.

Requirements

• Bachelor’s degree in engineering, science, regulatory affairs, or a related technical discipline required; advanced degree preferred or equivalent experience
• Bachelor’s degree with 5 years, or advanced degree with minimum 2 years relevant experience in medical device or combination product environments
• Experience supporting medical device development and/or regulatory activities across development, registration, and lifecycle management phases.
• Working knowledge of applicable regulatory and quality frameworks, including FDA quality management system requirements (QSR/QMSR), EU MDR, ISO 13485, and other relevant global standards and guidance documents.
• Demonstrated project management capability, including development and maintenance of integrated timelines, milestone tracking, risk and issue management, stakeholder communication, meeting facilitation, and escalation management.
• Strong written and verbal communication skills, with the ability to distill complex technical, regulatory, and quality information for cross-functional teams and leadership.
• Ability to work independently, manage competing priorities, and influence cross-functional stakeholders in a fast-paced, matrixed environment.
• Experience supporting successful FDA, EU MDR, or other global regulatory submissions and interactions with health authorities or notified bodies.
• Experience with Class II and/or Class III medical devices, combination products, drug delivery systems, SaMD/software-enabled devices, or packaging components used with pharmaceutical or biologic products.
• Familiarity with combination product requirements, device constituent part expectations, 21 CFR Part 4, software lifecycle documentation, cybersecurity, and usability/human factors requirements.
• Working knowledge of design control principles, including technical documentation, risk management (ISO 14971), verification and validation, change control, and product lifecycle management.
• Experience with medical device lifecycle activities, including change controls, complaints, CAPAs, post-market surveillance, technical documentation updates, and regulatory impact assessments.
• Experience working with pharmaceutical partners, contract manufacturers, notified bodies, health authorities, or other external regulatory stakeholders.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Nice-to-haves

• Advanced degree preferred or equivalent experience
• Regulatory Affairs Certification, Project Management Professional certification, or equivalent certification preferred.

Benefits

• Benefit programs that empower the physical, mental, emotional and financial health of our team members and their families
• Opportunities for lifelong learning, growth and development
• Commitment to creating a healthier environment and planet through sustainability efforts
• Giving back to help those in need in the communities where we live and work