Sr. Specialist, Regulatory Affairs, Medical Device
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.
POSITION SUMMARY: This role is responsible for in the coordination, authoring, submitting regulatory submissions (premarket notification, technical file, Master Access Files, etc.) for class II medical devices. This position includes supporting internal and external customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to West s products and services.
PRIMARY DUTIES AND RESPONSIBILITIES:
Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to Health Authorities [MAFs, 510(k) s, DMF s, etc.] in compliance with regulations, guidelines and procedures.
Acts as a regulatory representative on project development teams, communicates regulatory requirements and impact of regulations to the development team. Provides regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of West s or customer regulatory filings.
Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards.
Guide research initiatives relating to medical device and combination product development.
Reviews information to relating to medical device complaints.
Work with RA team to build Regulatory strategies for combination product development platform.
Review technical and design specifications, project documentation, regulatory plans, etc. providing guidance and direction where applicable.
Provide customers with West product related information and data as required for regulatory submissions to European and Rest of World agencies.
Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.
Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to West s products and business.
Develop specific objectives and manage work assignments, with minimal guidance, in an effort 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, Adobe, SharePoint and LOA request system, eCTD and others as required.
Education: Bachelor's, Master's degree, or PhD in related discipline, Science preferred
Experience: Bachelor's with 5-7; or Master's degree/PhD with 3-5 years regulatory/Pharma experience
Experience in regulatory medical device development and registration of class II medical devices.
Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
Awareness of regulations and guidelines related to preparation and administration of medicinal products.
Strong working knowledge of medical device and combination product regulations
Knowledge of pharmaceutical clinical development.
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
PHYSICAL & TRAVEL REQUIREMENTS:
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 disability or special need that requires accommodation, please send an email to ...@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. Associated topics: bilingual, care, clinic, family medicine physician, family practice, general practice, physician, physician md, practitioner, urgent
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.