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.
In this role, you will be responsible for in the coordination, authoring, submitting regulatory filings to regulatory agencies to obtain registrations / clearance for 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.
Essential Duties and Responsibilities:
Assisting in the preparation of regulatory documents in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to Health Authorities [DMFs, MAFs, 510(k) s] in compliance with regulations, guidelines and procedures.
Support communications with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.
Reviews information to relating to medical device complaints.
Participate on project development teams and provide regulatory guidance and communicate regulatory progress to cross functional teams.
Review technical and design specifications, project documentation, regulatory plans, etc.
Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
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 guidance, to achieve personal objectives in conformance with overall business goals
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 others as required.
Education: Bachelor's in related discipline
Experience: 1-3 years of regulatory /pharmaceutical experience
Preferred Knowledge, Skills and Abilities:
Experience in regulatory medical device development and registration of class I and class II medical devices.
Possesses technical skills and 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.
Knowledge of medical device and combination product regulations
Ability to manage multiple tasks/projects/priorities and simple 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.
5% (Meetings, Training)
Physical & Mental Requirements:
Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
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.
* 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.