Sr. Specialist, Regulatory Project Management

About the role

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.

Responsibilities

• 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.
• Career with Regulatory Affairs Leads and cross-functional subject matter experts to align regulatory strategy, technical deliverables, submission readiness, and lifecycle planning.
• 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

• Education: Bachelor’s degree in engineering, science, regulatory affairs, or a related technical discipline required; advanced degree preferred or equivalent experience.
• Experience: Bachelor’s degree with 5 years, or advanced degree with minimum 2 years relevant experience in medical device or combination product environments.
• Knowledge, Skills and Abilities: 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 QSR/QMSR, EU MDR, ISO 13485, and other relevant global standards and guidance documents; demonstrated project management capability; strong written and verbal communication skills; 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; Regulatory Affairs Certification, Project Management Professional certification, or equivalent certification preferred.

Qualifications

• Ability to work independently in a fast-paced, dynamic environment with requirement to adhere to multiple time-sensitive commitments.
• 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 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 comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
• Ability to write and record data and information as required by procedures.
• 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).