Senior Specialist, Regulatory Affairs

West Pharmaceutical Services; Exton (Chester County); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A leading company in healthcare seeks a Sr. Specialist in Regulatory Affairs to influence regulatory processes and ensure compliance. The role involves developing strategies, authoring submissions, and mentoring team members. This hybrid position requires expertise in medical device regulations and strong communication skills.

Qualifications

• 3-5 years of medical device regulatory experience with Bachelor's.
• Experience with US FDA regulations and EU regulations.

Responsibilities

• Develop and implement regulatory strategies for medical devices.
• Author and review submissions for US and EU markets.
• Provide leadership for regulatory issues and questions.

Skills

Attention to detail

Time management

Organizational skills

Regulatory compliance competency

Education

Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline

Tools

MS Word

MS Excel

MS Teams

MS PowerPoint

Master Control

Adobe

SharePoint

Job description

This is a hybrid role(3 days onsite) in Exton, PA. Candidates applying must be residing within a 50 mile commutable radius to the job location

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

TheSr. Specialist,Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications and Technical Documentation for CE Marking. T he Senior 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

Education

• Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline

Work Experience

• 3-5 years (with Bachelor) or 2+ years (with Masters/PhD)of medical device regulatory experience
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration, US 510(k) and/or EU technical documentation submissions

Preferred Knowledge, Skills and Abilities

• Advanced knowledge of ISO 13485
• 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.

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 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 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.

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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.