Sr. Regulatory Affairs Specialist (Medical Device)
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 company products and services.
location: Exton, Pennsylvania
job type: Permanent
salary: $110,000 - 120,000 per year
work hours: 9 to 5
- 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 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 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 company 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.
- Bachelor, Master's degree, or PhD in related discipline
- Bachelors with 3-5 years; or Master's degree/PhD with 1-3 years Medical Device / Combination Product regulatory experience.
- 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
skills: Regulatory Affairs Strategy
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.