This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. 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 Requirements5%: Up to 13 business days per year
Physical RequirementsSedentary-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).
#LI-DJ1 #LI-HYBRID
