Job Description
Who We Are: 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 Regulatory Affairs Principal is responsible for post market activities for Administration and Safety System medical devices. The Principal will influence department regulatory processes and procedures, supporting strategies for worldwide PMS activities. Responsible for leading projects in support of 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 FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to West's products and services. Essential Duties and Responsibilities: Accountable for Global Post Market Surveillance and Vigilance Activities for Administration and Safety System medical devices in West's portfolio. Support establishment and maintenance of procedures, work instructions, and templates associated with Post Market activities. Execute post-market surveillance plans in the commercial lifecycle including periodic review and reporting requirements. Collaborate with cross-functional team members in collecting, analyzing, trending, and reporting on safety and performance data to identify potential adverse safety risks or performance trends. Responsible for complaint monitoring and adverse event reporting globally. Ensure support of appropriate post market surveillance related submissions and reports to health authorities worldwide in accordance with local procedures. Lead and support the creation and streamline of processes to assure proactive surveillance (database searches, literature reviews) and reactive surveillance (complaints handling, field actions) is conducted efficiently. Actively collaborate in the generation of Post Market Clinical Follow-up Reports (PMCFR), Post Market Surveillance Plans (PMSP), Post Market Surveillance Reports (PMSR), Periodic Clinical Evaluation Report (CER), China NMPA Periodic Risk Evaluation Reports (PRER), 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). Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally. Develop specific objectives and manage work assignments, with minimal guidance to achieve objectives in conformance with global regulatory and business goals. Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting 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, Master Control, Adobe, SharePoint, MS Teams, Outlook, and others as required. Other duties as assigned. Education: Bachelor's, master's degree in nursing, engineering or related discipline Experience: Bachelor's with 10-12 years; Master's degree 8 years medical device, pharmaceutical or regulatory experience Advanced knowledge of US Class II and EU Class IIa device experience Advanced knowledge of 21 CFR , ISO 13485, ISO 14971, EU MDD (93/42/EEC) and MDR (2017/745) Advanced knowledge of global device adverse event reporting requirements Ability to work effectively in multinational/multicultural environment Ability to manage complex projects and timelines in a matrix team environment Strong interpersonal, communication, negotiation, and presentation skills Ability to navigate and utilize SAP for complaint processing Ability to independently identify compliance risks and escalate when necessary Preferred Knowledge, Skills and Abilities: International regulatory competency Advanced degree R.A.C certification(s) Experience with administration and drug delivery systems preferred Travel Requirements: Must be able to travel up to 5 - 10 % of the time (audits, meeting, training, industry events) Physical & Mental Requirements: Ability to research, read, analyze, and interpret regulatory and clinical 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 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. Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening. 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