Jobs

• 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 our client’s 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 our clients’ 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 or client’s 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.

Sr. Regulatory Affairs Specialist, Medical Device Skills & Experience:

• 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.
• 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.

Sr. Regulatory Affairs Specialist, Medical Device Travel Requirements:
5 – 10%  (meetings, trainings, projects)