Senior Specialist, Regulatory Affairs

RXinsider LTD.; Exton (PA); Hybrid; USD 110,000 - 170,000; Full time

Job summary

West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist to drive regulatory plans for medical devices and combination products. You will prepare global submissions, guide teams, and coordinate with agencies to ensure timely approvals.

This hybrid role requires strong leadership and regulatory know-how relevant to scope of products. The role emphasizes MDR/FDAs, lifecycle management, and post-market support.

Qualifications

• US Class II and EU Class IIa device experience with knowledge of US FDA regulations (21 CFR), EU MDD/MDR and ISO 13485.
• Knowledge of drug/device combination product global regulations and guidance.
• Understanding of product lifecycle, design control and change control.
• Experience with interactions with government agencies.
• Strong technical leadership and cross-functional collaboration.
• Commitment to regulatory compliance and quality policies.

Responsibilities

• Implement regulatory strategies for medical devices and combination products with emphasis on regional approvals.
• Prepare US, EU, and international submission sections (510k, IND, NDA, MAA, etc.) for products and changes.
• Author and review product submissions and assist with strategy and issues with regulatory bodies.
• Guide cross-functional teams to ensure documentation supports high-quality submissions.
• Review change controls for regulatory impact and reporting.
• Support EU RA office with complaints and Post-Market Surveillance.
• Maintain knowledge of worldwide regulatory requirements and agency relationships.
• Develop objectives and manage assignments to meet business goals.

Skills

FDA Regulations

EU MDR

Regulatory Submissions

Technical Writing

Cross-functional Leadership

Project Management

Combination Products

Agency Interaction

Quality Systems

GxP Knowledge

Education

Bachelor's in Science

Master's/PhD in Science

RAC Certification

Tools

MS Word

MS Excel

MS PowerPoint

MasterControl

Adobe

SharePoint

eCTD

Job description

Description

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 opportunity

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 Senior Specialist, Regulatory Affairs is expected to understand development of medical devices as applicable to combination products. To ensure, with minimal supervision, regulatory strategies are applied to regulatory submission documents to meet program requirements including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs. In addition, the Sr. Specialist 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

• Implement regulatory strategies for medical devices and combination products with an emphasis on gaining regional regulatory approval/clearance/license
• Prepare US, EU, and international submission sections (510k, IND, CTA, IMPD, NDA, BLA, MAA, etc.) for new products, product changes and information requests as required to ensure timely approvals for clinical studies and market release throughout the product life-cycle
• Author and review product submissions and assist with submission strategy and issues with regulatory bodies
• Provide guidance to global cross-functional teams to ensure documentation is accurately prepared with consideration to scientific rigor, accuracy, and clarity of presentation to support high quality global regulatory submissions
• Review change controls to determine impact and reportability to existing regulatory filings
• Supports EU RA office with complaints and Post Market Surveillance of marketed products
• Maintain proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• 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 preferred or
• PhD in science, math, engineering, or related discipline preferred or
• Advanced degree preferred

Work Experience

• Minimum 5 years of experience with Bachelor’s degree or
• Minimum 2 years of experience with Master’s degree/PhD in medical device regulatory required

Preferred Knowledge, Skills And Abilities

• US Class II and EU Class IIa device experience and knowledge of US FDA regulations (Title 21), EU MDD (93/42/EEC) and MDR (2017/745), 21 CFR 820, 210, 211 and ISO 13485
• Knowledge of drug / device combination product global regulations and guidance’s
• Understanding of product life cycle, product development process, design control and change control
• Experience with interactions with government agencies
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
• Strong negotiation and decision-making skills
• Excellent oral communication and technical writing skills
• Experience with combination product delivery systems
• 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)-RAPS R.A.C certification(s) preferred

Travel Requirements

5%: Up to 13 business days per year

Physical 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.

Additional Requirements

• Ability to work in sedentary environment, in an office; may need to stand or sit for extended periods of time
• Ability to communicate effectively, speak in front of groups, express & exchange ideas and understand direction
• 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 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 flexible with changing priorities and comply with constantly changing regulatory procedures
• Maintain working knowledge of computer software packages including eCTD, MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint and others as required

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 [e-mail] . 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.