West Pharmaceutical Services · 19 hours ago
Sr. Specialist Regulatory Affairs, MD
Exton, PA
Full-time
Hybrid
Mid, Senior Level
3+ years expWest Pharmaceutical Services is a company dedicated to improving patient lives through innovative healthcare solutions. The Regulatory Affairs Sr. Specialist will be responsible for developing and implementing regulatory strategies for medical devices, ensuring compliance with global regulations, and mentoring team members while managing regulatory submissions and customer requests.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
Develop and implement medical device regulatory strategies for West’s Transfer Devices with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner
Author and review US, EU, Japan, China and additional international submissions with guidance for new products, product changes and post-market updates as required to ensure timely approvals for market release and file maintenance
Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
Provide leadership to product development teams for regulatory issues and questions
Provide support to market-released products as necessary, including reviewing labeling, promotional material, product/manufacturing process changes, post-market reporting and documentation
Establish and maintain good working relationships with agency personnel
Compile and maintain regulatory databases or systems as well as technical documentation required for new or modified products
Create documentation in response to customer regulatory requests which include regulatory letters, technical packages, etc
Write or update standard operating procedures, work instructions, or policies
Cleary 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
Maintain effectiveness when experiencing major changes in work responsibilities or environment adjusting effectively to work within new work structures, processes, requirements, or cultures
Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
Other duties as assigned
Qualification
Required
Education: Bachelor's, Master's degree or PhD in science, math, engineering, or related discipline
Experience: Bachelor's with 5+ years; Master's degree/PhD with 3+ years of medical device, pharmaceutical or regulatory experience
Bachelor's with 5+ years of medical device, pharmaceutical or regulatory experience
Master's degree/PhD with 3+ years of medical device, pharmaceutical or regulatory experience
Develop and implement medical device regulatory strategies for West's Transfer Devices with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner
Author and review US, EU, Japan, China and additional international submissions with guidance for new products, product changes and post-market updates as required to ensure timely approvals for market release and file maintenance
Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
Provide leadership to product development teams for regulatory issues and questions
Provide support to market-released products as necessary, including reviewing labeling, promotional material, product/manufacturing process changes, post-market reporting and documentation
Establish and maintain good working relationships with agency personnel
Compile and maintain regulatory databases or systems as well as technical documentation required for new or modified products
Create documentation in response to customer regulatory requests which include regulatory letters, technical packages, etc
Write or update standard operating procedures, work instructions, or policies
Cleary 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
Maintain effectiveness when experiencing major changes in work responsibilities or environment adjusting effectively to work within new work structures, processes, requirements, or cultures
Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
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
Preferred
Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Able to comply with the company's safety and quality policy at all times
International regulatory competency
Knowledge of 21 CFR 820/ISO 13485
Possesses technical leadership skills, as well as demonstrated understanding of related medical device and pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
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
Experience directly interacting and presenting to project teams and customers
Strong negotiation and decision-making skills
Excellent written and verbal communication, timeline management skill
Self-motivated with a proactive attitude and the ability to work effectively
Regulatory compliance competency including Quality Systems
Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2025-12-06
Company data provided by crunchbase