Senior Specialist, Regulatory Affairs

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This is a hybrid position, 3 days a week onsite in our Dublin location.

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. 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?

Job Summary

The Regulatory Affairs Sr. Specialist is responsible for post market activities for medical devices, supporting department regulatory processes and procedures, supporting strategies, authoring, reviewing, and supporting global registrations. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties And Responsibilities

• Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines, evolving regulations and industry standards.
• Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF and vigilance reports to Notified Bodies, EMA, and other global competent authorities.
• Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in West's portfolio.
• Support West's medical device EU importation requirements as Importer in accordance with Article 13 of MDR.
• Provide technical review of data and reports supporting regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation are fit for purpose.
• Collaborate with cross-functional teams and external stakeholders to provide guidance, issue resolution, responses to inquiries, and actions taken.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals.
• Adhere to all applicable government requirements and West practices, and procedures to maintain compliance.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.

Education

• Bachelor's Degree in science, math, engineering, or related discipline required
• Master's Degree in science, math, engineering, or related discipline preferred
• PhD in science, math, engineering, or related discipline preferred

Work Experience

• Experience: Bachelors with +5 years or master's degree/PhD with 3+ years of medical device regulatory experience
• Experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485 and US FDA regulations (Title 21CFR820), ISO 14971, and ISO 14155, EU combination product regulations
• Experience in preparation of dossiers for submission to competent authorities including supporting design and development of medical devices and combination products over the product lifecycle
• Strong decision-making, communication, and technical writing skills
• Ability to work independently and manage multiple priorities and to follow established processes while identifying areas for process improvement

Licenses And Certifications

• Regulatory Affairs Certifications (RAC) – RAPS RAC certification(s) preferred

Preferred Knowledge, Skills And Abilities

• Established scientific and quality expertise as described above
• Experience in direct engagement with regulatory authorities
• Regulatory compliance competency in Quality Management Systems
• Knowledge of US FDA regulations and submission pathways (e.g., 510(k), DMF, MAF, BLA)
• Familiarity with US drug-device and ROW combination product requirements
• Advanced degree and/or RAC certification

Additional Requirements

• Ability to work in a sedentary office environment; may need to stand or sit for extended periods.
• Ability to comprehend principles of math, science, engineering, and medical device use; handle regulatory and quality documentation with confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical terminology, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data; organize complex information.
• Ability to make decisions considering risks and benefits of actions.
• Ability to plan, schedule and manage multiple projects and deliverables to time-line commitments.
• Ability to work effectively in cross-functional and matrix teams.
• Ability to adapt to changing priorities and regulatory procedures.
• Ability to build strong relationships internally and externally.
• Ability to work in a fast-paced environment.
• Proficiency with Microsoft Office Suite and Adobe Acrobat, and other required tools.

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary – Exerting up to 10 lbs/4 kgs of force occasionally, and/or negligible amount of force to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Equal Employment Opportunity

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 Where permitted by law, an offer of employment is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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