Job Summary: The Regulatory Affairs Associate is responsible for assisting with the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives. The Regulatory Affairs Associate reports to and will work with the Manager of Regulatory Affairs to develop, implement, and maintain regulatory activities for Vygon USA.
Assist in the preparation and maintenance of medical device submissions (510(k)s and Health Canada Licenses).
Assist with the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
Coordinate with manufacturing contacts on product changes and regulatory notification/approval requirements.
Assist in recalls and advisory notices.
Review complaints for US and Canadian reporting requirements; prepare and submit reports as necessary.
Work with Quality, Engineering and Operations in evaluating product labeling changes.
Maintain the Vygon USA GUDID database.
Update departmental procedures as required.
Responsible for assembly/verification of archival regulatory documentation.
Maintain applications and renewals of state pharmacy licenses.
Work closely with Marketing in reviewing advertising and promotional materials.
Maintain up to date knowledge on US and Canadian regulatory requirements.
Files MDR’s as required
Assist QA with product handling and disposition
Assist with internal auditing
Other duties assigned
Education and Experience:
Bachelor’s degree scientific discipline (preferably Engineering or Life Sciences)
Minimum of 3 years of direct or indirect Regulatory Affairs in Medical Device.
Knowledge of global medical device regulations.
Must demonstrate ability to interpret regulatory standards and guidance.
Knowledge, Skills and Abilities:
Must be self-motivated and self-disciplined with ability to prioritize/handle multiple tasks and responsibilities.
Must be proficient in MS Office.
Must have good interpersonal skills and the ability to interface with all levels of the organization and outside customers.
Must have excellent verbal and written communication skills
Internal Number: 001
About Vygon US
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.