Overview
This is a hybrid position: 3 days a week onsite in Dublin. The Senior Associate, Regulatory Affairs will support post-market activities for Administration and Safety System medical devices, with input from management.
West Pharmaceutical Services is a company focused on improving patient lives through the delivery of life-saving injectable medicines. This description preserves the core responsibilities and qualifications of the role while removing extraneous or irrelevant content.
Job Summary
The Senior Regulatory Affairs Specialist is responsible for post-market activities for Administration and Safety System medical devices. The role supports department regulatory processes and procedures, strategies for worldwide PMS activities, post-market activities, adverse event reporting, and device risk management during design and development. Maintain knowledge of current US, EU and international regulations/guidelines/policies related to medical devices as applicable to West’s products and services.
Essential Duties and Responsibilities
* Complete global Post Market Surveillance (PMS) activities for Administration and Safety System medical devices in West’s portfolio.
* Support establishment and maintenance of procedures, work instructions, and templates associated with PMS activities.
* Responsible for complaint monitoring and adverse event reporting globally.
* Author PMS plans, PMS reports including Periodic Safety Update Reports (PSUR), China NMPA PRER, Canada Summary Reports, and other reports required by health authorities; support maintenance of DHF and RMF.
* Assist in creating streamlined processes for proactive and reactive surveillance (database searches, questionnaires; complaints handling, field actions).
* Collaborate with cross-functional teams to collect, review, analyze, and report safety and performance data to identify risks or trends.
* Collaborate with RA submission teams to support regulatory submissions and approvals globally.
* Maintain adaptability to changes in responsibilities, structures, processes, or policies.
* Maintain knowledge of computer software including MS Word, MS Excel, MS PowerPoint, SharePoint, MasterControl, Adobe, MS Teams, Outlook, and other required tools.
* Adhere to applicable regulations, practices, and procedures to maintain compliance.
* Operate in accordance with the company’s Guiding Principles and Code of Conduct; comply with Environmental, Health and Safety regulations and company policies.
* Other duties as assigned.
Education
* Bachelor's Degree in science, math, engineering, or related discipline required.
* Master's Degree in science, math, engineering, or related discipline or PhD preferred.
* Regulatory Affairs Certification (RAC) preferred.
Work Experience
5+ years (with bachelor’s degree) or 3+ years (with Master’s/PhD) of medical device regulatory experience.
Preferred Knowledge, Skills and Abilities
* Advanced knowledge of global device adverse event/incident reporting requirements
* Attention to detail, planning, time management, and organizational skills
* Experience with US Class II and EU Class IIa devices
* Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745)
* International regulatory competency; strong written and oral communication skills
* Experience with Administration and Safety Systems preferred
* Self-motivated with a proactive attitude; able to work effectively in a fast-paced environment
* Compliance with safety and quality policies at all times
Travel
Up to 5%: up to 13 business days per year
Physical Requirements
Sedentary work; ability to occasionally lift up to 10 lbs/4 kg; sit for extended periods.
Additional Information
West is an equal opportunity employer. We value diversity and do not discriminate based on race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability. If you require accommodations to apply, please email Apply.Accommodation@westpharma.com. Where permitted by law, employment is contingent upon background screening and/or pre-employment drug screening.
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