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Title:  Principal, Regulatory Affairs - Combination Products (Remote)

Requisition ID:  35183
Date:  Jan 12, 2022
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs
Description: 

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.

 

The Principal Regulatory Affairs Specialist is expected to perform with minimal supervision and is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing global submissions, and ensuring timely and high-quality execution of all regulatory deliverables.  In addition, the Principal Specialist mentors other regulatory specialists, and provides support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests. This position can accommodate a remote work location.

 

Essential Duties and Responsibilities:
•    Develop and implement medical device and combination product regulatory strategies with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices and combination products in the most efficient, compliant manner. 
•    Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
•    Prepare US, EU, and international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release
•    Review complex product submissions with manager or other senior management and negotiate submission issues with Agency personnel. All significant issues will be reviewed with the manager and/or other senior management.
•    Work with RA team to build Regulatory strategies for combination product development platform.
•    Prepare regulatory strategies/plans and worldwide requirement lists. Provide leadership to product development teams for regulatory issues and questions
•    Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval.
•    Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
•    Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
•    Prepare submissions and reports for FDA and support other major market regulatory agencies as required by product status.
•    Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions
•    Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel
•    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.
•    Write or update standard operating procedures, work instructions, or policies
•    Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.
•    Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
•    Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
•    Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.
•    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 Project, MS PowerPoint, Master Control, Adobe, SharePoint and LOA request system, eCTD and others as required.
•    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 4-6 years; Master’s degree/PhD 2-4 years medical device/combination products regulatory experience 
•    Minimum US Class II and EU Class Ia sterile device experience and in-depth knowledge of US FDA regulations (Title 21) and EU medical device directive (93/42/EEC) and EU medical device regulations MDR 2017/745
•    History of successful US 510(k) device and EU technical files submissions
•    Advanced knowledge of 21 CFR 820/ISO 13485
•    Advanced knowledge of product life cycle, product development process, design control and change control
•    Experience directly interacting with government agencies
•    Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).  
•    Experience reviewing product labeling and advertising/promotional material for medical devices
•    Strong negotiation and decision-making skills
•    Excellent oral communication and technical writing skills
•    Self-motivated with a proactive attitude and the ability to work effectively

 

Preferred Knowledge, Skills and Abilities:
•    Knowledge of software as a medical device
•    Experience with regulatory Inspections and Field Actions
•    Regulatory compliance competency including Quality Systems 
•    International regulatory competency
•    Advanced degree 
•    R.A.C certification(s)
•    Experience with US De novo and Class III device submissions, including IDE and software-containing devices and medical device capital equipment and IEC 60601-1:2005
•    Experience with administration and drug delivery systems preferred

 

Travel Requirements:
•    Must be able to travel up to 5 – 10 % of the time 
 

 

 

 

 

 

 

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.

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