Title:  Senior Specialist, Regulatory Affairs

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 and field safety corrective actions 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 or
• Master's Degree in science, math, engineering, or related discipline preferred or
• 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 (e.g., EMA/CHMP/QWP/BWP/259165/2019)
• 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 ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement in a changing environment

License and Certifications

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

Preferred Knowledge, Skills and Abilities

• Established scientific and quality expertise with criteria 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 sedentary environment, in an office; may need to stand or sit for extended periods of 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 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.
• 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).

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Travel Requirements

Physical Requirements