Title:  Senior Manager/Director, EU Regulatory Affairs

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 Senior Manager/Director serves as a subject matter expert in the implementation, execution and maintenance of West’s (EU) 2017/745 regulatory processes and procedures for medical devices and combination products whilst also providing regulatory intelligence support and strategic regulatory advice.

This role serves as a key strategic partner with the development and commercialization teams and works closely with the broader regulatory matrix team to conceive and deliver successful registration and life-cycle management of standard and technologically complex delivery systems targeted for the EU market. The Senior Manager/Director will influence cross-functional internal activities concerning the EU market and will work with external customers, Notified Bodies (NB) and health authorities to plan, obtain and maintain EU Opinions and CE marks for West integral and non-integral medical devices, respectively. This role is responsible for driving continuous improvement in the day-to-day operations of the regulatory and quality functions and seeks opportunities to continually enhance cross-functional effectiveness across the organization in line with corporate goals. This role and the regulatory team must proactively maintain an understanding of EU health authority guidelines, regulations, and best practices to establish regulatory strategies to support West product portfolio.
 

Essential Duties and Responsibilities:

• Lead in the development, execution and oversight of EU regulatory strategies for medical device and drug device combination products, in alignment with the overall development plan and enterprise goals, whilst maintaining contemporaneous knowledge of latest EU regulatory developments.
• Collaborates with cross-functional stakeholders (Quality Assurance and Research & Development) to ensure regulatory compliance is maintained and regulatory deliverables are achieved.
• Collaborate with external partners to ensure regulatory compliance is maintained and regulatory deliverables are achieved.
• Identifies, communicates, and achieves stakeholder alignment on priorities for scientifically sound approaches to gain CE marking of medical devices and support combination product registrations.
• Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks
• Author complex product submissions and ensure all regulatory activities and documents, to be submitted to regulatory agencies and Notified Bodies, have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, and are in regulatory compliance.
• Responsible for engaging, and maintaining relationships, with National Competent Authorities, Notified Bodies and Authorized Representatives.
• Actively participate, as required, in company governance for combination products and delivery systems including contract development, portfolio review, project leadership teams, steering committees, as required.
• Provide post-market support to market-released products as necessary (e.g. change control, post-market surveillance).
• Collaborates with Regulatory Policy & Intelligence in maintaining up-to-date knowledge of EU regulatory policy trends and developments.
• Creation, review and maintenance of EU regulatory SOPs.
• Acts as a delegate for the Senior Director, EU Regulatory Affairs.
• 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 10-12 years; Master’s degree/PhD + 8 years medical device, pharmaceutical or regulatory experience.

Preferred Knowledge, Skills and Abilities:

• Advanced knowledge of the European Medical Devices Regulation, (EU) 2017/745, and associated guidance (e.g. MDCG Guidance Documents) and Quality Management System requirements (i.e. ISO 13485).
• Advanced knowledge of medical device ‘horizontal’ international standards (e.g. ISO 14971 and ISO 14155).
• Advanced knowledge of product life cycle, product development process, design control and change control.
• Advanced Knowledge of European regulatory requirements for drug-device ‘combination products’ (e.g. EMA/CHMP/QWP/BWP/259165/2019 and EMA/37991/2019).
• Advanced knowledge of EU Authorized Representative and Person Responsible for Regulatory Compliance (PRRC) requirements.
• Experience in directly interacting with national Competent Authorities and Notified Bodies.
• Experience in medical device design and development (minimum class IIa).
• Experience in Technical Documentation (EU MDR and/or EU MDD) and CE marking of medical devices (minimum Class IIa medical devices).
• Excellent oral communication and technical writing skills
• Self-motivated with a proactive attitude and the ability to work effectively
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Experience in US FDA requirements relating to medical device and combination products.
• Experience in EU Post Market Surveillance (PMS) requirements.
• Knowledge of UK and Swiss medical device and combination product regulatory requirements.
• Knowledge of EU and US medicinal product regulatory submission requirements (e.g. MAA, NDA, ANDA).
• 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 – 10 % 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.