Sr. Specialist, Regulatory Project Management

Sr. Specialist, Regulatory Project Management

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary 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.

Essential Duties and 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.

Education & Experience 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 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. Regulatory Affairs Certification, Project Management Professional certification, or equivalent certification preferred.

Travel Requirements 5%: Up to 13 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements 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 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 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).

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to View email address on click.appcast.io . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.