Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week at our Exton PA.

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.

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 / licence 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 degree or equivalent experience is required

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).

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.

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.