Principal, EU Regulatory Affairs, Medical Devices (63921)

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?  

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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 Regulatory Affairs Principal is responsible for influencing department regulatory processes and procedures, developing strategies for EU regulatory approval, preparing technical documentation for EU submissions for West’s portfolio of Administration and Safety Systems . The Regulatory Affairs Principal ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Regulatory Affairs 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:

• Development and execution of EU regulatory strategies for sterile medical device products in West’s Administration and Safety System portfolio, in alignment with the overall development plan and enterprise goals, while maintaining knowledge of the latest EU regulatory developments.
• Liaise and serve as back-up to Person Responsible for Regulatory Compliance (PRRC) for Administration Systems
• 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.
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
• 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.
• Provide post-market support to market-released products as necessary (e.g. change control, post-market surveillance).
• Collaborate with Regulatory Policy & Intelligence team to assure up-to-date knowledge of EU regulatory policy trends and developments are maintained.
• Creation, review and maintenance of EU regulatory Standard Operating Procedures (SOPs), work instructions, or policies and support the operations of the EU RA Office.
• Other duties as assigned.

Basic Qualifications:  

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

• Experience: Bachelor’s with 8+ years; Master’s degree/PhD with 4+ years Regulatory Affairs experience supporting medical device products or equivalent 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).
• Knowledge of medical device ‘horizontal’ international standards (e.g. ISO 14971).
• Experience design and development of sterile medical devices.
• Experience in Technical Documentation compilation, review, and submission for medical devices
• Excellent oral communication and technical writing skills
• Self-motivated with a proactive attitude and the ability to work effectively

• Experience in directly engaging with health authorities (e.g. pre-submission meetings, responses to regulatory information requests etc.).
• Experience with EU Post Market Surveillance (PMS) requirements.
• Knowledge of US FDA regulations on medical devices.
• Advanced degree. 
• R.A.C certification(s).
• Experience with administration and safety systems preferred (co-packaged).

Travel Requirements:

• Must be able to travel up to 15 %of the time

Physical and Mental Requirements:

• Ability to work in sedentary environment, 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 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 work in a fast-paced environment.
• Ability to verbally communicate ideas and issues effectively to other team members and management. 
• 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).

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.