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Sr Specialist - Combination Product Regulatory Affairs

Requisition ID:  17592
Date:  Apr 27, 2021
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs

Sr Specialist - Combination Product Regulatory Affairs   

Exton

Pennsylvania    

 

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 $1.84B in 2019. 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.

 

POSITION SUMMARY: This role is 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.

 

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 regulatory agencies [MAFs, 510(k)’s, technical files] in compliance with regulations, guidelines and procedures.
  • Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of 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.
  • Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.
  • 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 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.

 

REQUIRED QUALIFICATIONS:

  • Education:  Bachelor, Master’s degree, or PhD in related discipline
  • Experience: Bachelors with 3-5 years; or Master’s degree/PhD with 1-3 years Medical Device / Combination Product regulatory experience.

 

PREFERRED QUALIFICATIONS:

  • Education: Bachelor Science of Nursing (BSN) or equivalent clinical degree
  • Experience in Medical Device Post Market Surveillance, Clinical Evaluation Reports, Heath Hazard Evaluation
  • Experience in regulatory medical device development and registration of class I and 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: 

  • 5 - 10%  (meetings, trainings, projects)

 

 

 

 

 

 

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 peggy.tayloe@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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