Principal Specialist, Regulatory Affairs

Principal Specialist, Regulatory Affairs

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.

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. 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.

Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively. Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusionwhere all voices are heard and respected in a supportive environment. Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

Job Summary

The Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing global submissions including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking, and Health Canada submissions. The Principal Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Principal Specialist mentors team members, and provides support for global regulatory approvals (beyond US and EU), commercialized products, 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 administration and safety systems with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. Author and review complex product submissions guidance and negotiate submission issues with Agency personnel. Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations. Prepare US, EU, and other international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Work with RA team to build Regulatory strategies for medical device development platform. Prepare regulatory strategies/plans and worldwide requirement lists. Provide leadership to product development teams for regulatory issues and questions. Provide support to market-released products as necessary, including review of labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval. Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. 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. Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint and others as required. Prepare submissions and reports for FDA and support other major market regulatory agencies as required. Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions. Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel. 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. Write or update standard operating procedures, work instructions, or policies. Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management. Other duties as assigned.

Education

Bachelor's Degree science, math, engineering, life sciences or related discipline required.

Work Experience

Minimum 8 years related work experience required. Medical device or Combination Product regulatory experience preferred. Bachelor's with 4-6 years experience or Master's degree/PhD 3-4 years medical device regulatory experience.

Preferred Knowledge, Skills and Abilities

Excellent oral communication and technical writing skills Advanced knowledge of product life cycle, product development, design control and change control. International regulatory competency. Experience with administration and safety systems preferred Minimum US Class I and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745) History of successful US 510(k) device and EU technical documentation submissions. Experience directly interacting with government agencies. Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). Experience reviewing product labeling and advertising/promotional material for medical devices. Strong negotiation and decision-making skills. Self-motivated with a proactive attitude and the ability to work effectively. Ability to manage multiple priorities.

License and Certifications

RAPS Regulatory Affairs Certifications (RAC)-Medical Devices - Upon Hire preferred

Travel Requirements

10%: Up to 26 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

Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required. Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance. 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 View email address on click.appcast.io . 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.