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. 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 Regulatory Affairs Specialist is expected to perform with input from management and is responsible for post-market activities for Administration and Safety System medical devices. The Senior Specialist will support department regulatory processes and procedures, supporting strategies for worldwide PMS activities. Responsible for supporting products/projects with regards to product Post Market activities, Adverse Event Reporting, and device risk management throughout various stages of design and development of Administration and Safety Systems. 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 and assignments 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 with guidance to create PMS Plans, PMS Reports including Periodic safety update reports (PSUR), China NMPA Periodic Risk Evaluation Reports (PRER), Canada Summary Reports and other reports required by various health authorities along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF).
- Support the creation and streamline of processes to assure proactive surveillance (database searches, questionnaire) and reactive surveillance (complaints handling, field actions) is conducted accurately and efficiently.
- Collaborate with cross-functional team members in collecting, reviewing and analyzing and reporting on safety and performance data to identify potential adverse safety risks or performance trends.
- Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally.
- Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures.
- Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, SharePoint, MasterControl, Adobe, MS Teams, Outlook, and others as required.
- Adhere to all applicable regulations, practices, and procedures to maintain compliance.
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all local site Environmental, Health and Safety regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Other duties as assigned.
Education
- Bachelor's Degree in science, math, engineering, or related discipline required or
- Master's Degree in science, math, engineering, or related discipline or
- PhD in science, math, engineering, or related discipline
Work Experience
5+ years (with bachelor’s degree) or 3+ years (with Master’s/PhD degree) of medical device regulatory experience.
Preferred Knowledge, Skills and Abilities
- Advanced knowledge of global device adverse event/incident reporting requirements
- Attention to detail with planning, time management and organizational skills
- Minimum US Class II and EU Class IIa device experience
- Knowledge of 21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) and ISO 14971
- International regulatory competency
- Good oral communication and technical writing skills
- Experience with administration and safety systems preferred
- Self-motivated with a proactive attitude and the ability to work effectively
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
License and Certifications
- Regulatory Affairs Certifications (RAC) preferred
Additional 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.
- 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 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 be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
Travel Requirements
Physical Requirements
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 [email protected]. 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 and/or a pre-employment drug screening.
