This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week No relocation is provided for this opportunityJob SummaryThe Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. 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- Develop and implement medical device regulatory strategies for West's administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
- Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
- Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
- Provide leadership to cross functional teams for regulatory issues and questions.
- Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
- Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
- 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 and West regulations, 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
- Other duties as assigned
Education- Bachelor's degree or equivalent experience is required or
- Master's degree or PhD in science, math, engineering, or related discipline preferred
Work Experience- Minimum 5 years of relevant experience
- 2+ years of medical device regulatory experience preferred
- Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
- History of successful international device registration,
- EU MDR technical documentation and/or US 510(K) authoring experience
- Advanced knowledge of ISO 13485
- Advanced knowledge of product life cycle, product development process, design control and change control
- Experience interacting with government agencies
- Excellent oral communication, technical writing, and decision-making skills
Preferred Knowledge, Skills and Abilities- Attention to detail with planning, time management and organizational skills
- Regulatory compliance competency including Quality Systems
- Experience with administration and safety systems preferred
- Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement
Additional Requirements- 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). #LI-NJ1 #LI-Hybrid
License and Certifications- Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
Travel Requirements5%: Up to 13 business days per year
Physical RequirementsSedentary-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.
