Title:  Principal Regulatory Affairs (Post-market)

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

The Regulatory Affairs Principal serves as a key member of the regulatory affairs team and is expected to perform with minimal supervision. The Principal is responsible for influencing department regulatory processes and procedures, contributing to and implementing strategies for post-market activities related to West’s medical devices and combination products. The Principal ensures timely and high-quality execution of all regulatory deliverables. In addition, the Principal 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:

• Contribute to and implement global post-market / life-cycle management regulatory strategies for medical devices and drug device combination products.
• Collaborate with cross-functional stakeholders, provide technical review of proposed changes (i.e. change control) and determination of reportability to global health authorities, Notified Bodies and other agencies as required.
• Ensure technical documentation supporting approved products is maintained and manage recertification activities.
• Collaborate with external partners to ensure continued regulatory compliance is maintained and regulatory deliverables are achieved for on-market products.
• Collaborate with cross-functional stakeholders on post-market surveillance activities including regulatory reporting of adverse events in line with global regulatory requirements.
• Collaborates with Regulatory Policy & Intelligence in maintaining up-to-date knowledge of global regulatory policy trends and developments as it pertains to lifecycle management and impact on West’s product portfolio.
• Creation, review and maintenance of regulatory Standard Operating Procedures (SOPs), work instructions, or policies.
• Other duties as assigned.

Basic Qualifications: 

• Education: Bachelor’s, Master’s degree or PhD in science, math, engineering or related discipline or equivalent experience.

• Experience: Bachelor’s with 8-10 years; Master’s degree/PhD with +4 years Regulatory Affairs experience supporting medical devices and/or drug-device combination products.

Preferred Knowledge, Skills and Abilities:

• Advanced knowledge of global medical device and combination product post-market regulatory requirements including: European Medical Devices Regulation (EU) 2017/745, ISO 13485 and US FDA 21 CFR 820.
• Experience in medical device and/or drug-device combination product design and development, change control and post-market surveillance.
• Experience in Technical Documentation compilation, review, and submission for medical devices and/or drug-device combination products.
• Experience directly engaging with global health authorities and/or notified bodies.
• Excellent oral communication and technical writing skills
• Self-motivated with a proactive attitude and the ability to work effectively
• Knowledge of EU and US medicinal product (including drug led combination products) post-market regulatory requirements (e.g. variations).
• Advanced degree. 
• R.A.C certification(s).
• Experience with administration and drug delivery systems preferred (single integral and co-packaged).

Travel Requirements:

• Must be able to travel up to 5 – 15 % of the time (meeting, trainings, projects, industry events), including international travel.

Physical & Mental Requirements:

• Sedentary environment; ability to work in an office; may need to stand or sit for extended periods of time.
• 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).

Competencies/Authorities

• Non-US only where required for certain levels.

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 Apply.Accommodation@westpharma.com.  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 and/or a pre-employment drug screening.