Job Summary: The Regulatory Affairs Manager is responsible for managing the preparation and submission of regulatory documentation for medical device filings. In addition, the Regulatory Affairs Manager will be directly involved in writing regulatory documents that are used to request regulatory clearance for Health Canada and FDA (U.S. Food and Drug Administration) approval for devices. This position reports directly to the CEO. This remote position requires an individual within commuting distance of either Dover, NH or Lansdale, PA. Visa sponsorship is not available for this position.
Collaborates with the senior leadership team to develop regulatory strategies and plans for Vygon US products
Prepares and submits US regulatory submissions (510(k)’s)
Prepare and submit Canadian regulatory submissions (Licenses)
Keep current with medical device regulations
Ensure that establishment, device and other licenses are kept up to date
Review product conformance and assure compliance
Register products according to provincial guidelines and regulations of third party suppliers
Assures the quality system is compliant with associated regulations and metrics are being utilized.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
Links with authorities and serves as a liaison between the company and various governmental agencies.
Ensures appropriate regulatory support for new product development and that post market commitments are met in line with strategic plan and business priorities:
Provides strategic regulatory input to development programs for regulated products.
Serves as regulatory management representative in business unit cross functional committees or boards such as the research board, risk evaluation committee and cross functional commercial teams.
Contributes to efforts on process improvement, talent management and other management initiatives to maintain regulatory affairs.
Ensure regulatory compliance of product and process
Responsible for assembly/verification of archival regulatory documentation
Prepare and review documents intended for submission to regulatory agencies for compliance/continuity and recommend revisions as necessary
Ensures all affected parties are kept abreast of regulatory issues affecting products and projects
Provide guidance on regulatory compliance, counsel technical, and business groups to establish direction based on available data and regulatory considerations
Support the creation, review, approval and improvements of all labeling and advertising both internally and externally
Review acceptability and regulatory status of new products, ingredients, and processes
Approves all product claims and is responsible for ensuring claim substantiation
Review QC documents relating to product stability and shelf life
Ensure the completion and review the content of audits for regulatory compliance
Maintains adequate knowledge and expertise in product regulatory and environmental compliance requirements
Education and Experience:
Bachelor’s degree in Life Sciences or related field
Certificate in Regulatory Affairs preferred
8+ years of experience in regulatory affairs in the medical device industry
Experience in product development of medical devices a plus
Experience interacting with FDA regarding regulatory matters
Solid experience and proven track record in FDA successful submissions of 510K
Must have a strong experience in understanding of GMP and ISO standards and knowledge of standard inspection methods and SPC.
Skills and Abilities
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, drawings and procedure manuals.
Must process strong written and verbal skills and organizational skills.
Ability to speak and present effectively in a group setting
Ability to write routine reports and correspondence
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
Ability to problem solve
Must process a strong attention to detail and be a team player
Vygon USA strives to improve care and save lives. We manufacture and distribute medical device solutions specializing in neonatal, vascular access, and USP approved products. We utilize the latest manufacturing technologies and offer our products through a fully trained, professional network of direct sales representatives and specialty distributors.
Every activity we undertake, every employee we hire, and every policy we enact must reflect our core values:
• Patient first – the needs of the patient come first, always.
• Flexible – willing to learn, create new ideas and adapt to new environments.
• Passionate – the fuel that inspires us individually and collectively and drives our company forward.
• Respect - We treat our team members, customers, partners and suppliers with mutual respect and sensitivity, recognizing the importance of diversity. We respect all individuals and value their contributions.