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
- 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.
- 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.