Regulatory Affairs Specialist

  • location: Exton, PA
  • type: Permanent
  • salary: $60,000 - $75,000 per year
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job description

Regulatory Affairs Specialist

job summary:
In this role, you will be responsible for 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 our products and services.

 
location: Exton, Pennsylvania
job type: Permanent
salary: $60,000 - 75,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of submissions to Health Authorities [MAFs, 510(k)'s, Technical File], customer requests, etc. in compliance with regulations, guidelines and procedures.
  • Support project development teams and communicate regulatory progress, decisions, strategies, etc.
  • Support DVT strategy and related documents review.
  • Support pre-clinical studies and international clinical studies.
  • Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
  • Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires).
  • 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 and seek better alternatives and drive change.
  • Adhere to all applicable government and company regulations, practices and procedures to maintain compliance.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.
  • 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.
 
qualifications:
  • Bachelor's degree required with an emphasis in Science or related disciplines
  • 3-5 years of medical device / pharmaceutical experience specific related with medical device constituent of combination product, design control activities
  • Knowledge of medical device regulatory affairs and design control process and management of regulatory support systems is a plus.
  • Experience in regulatory medical device development and registration of class I and class II medical devices.
  • Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required.
  • Excellent interpersonal, communication and listening skills.
 
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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