This position will coordinate and document internal and external regulatory processes to support worldwide compliance requirements. The position may compile and prepare materials for submission to regulatory agencies.
Prepare global regulatory files/submissions for product registration as assigned.
Develop and maintain EU technical files and/or design dossiers to new EU MDR standards.
Provide regulatory support for on-going globally product registrations as assigned.
Review and approve proposed design changes and ECOs to assess regulatory impact.
Participate on project and product development teams to provide early guidance, design control reviews, and Regulatory Strategy.
Review and approve labeling for domestic and international compliance including meeting US and EU UDI requirements.
Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
Coordinate Certificates to Foreign Governments, Free Sales Certificates, Apostilles, and notarization.
Maintain regulatory data, GUDID, and FDA medical device listings.
Perform other related duties and special projects as required by management.
Bachelor of Science Degree in technical, engineering, and/or scientific discipline. Professional designations are not required but training and certificates in regulatory affairs are a plus.
Minimum 2-3 years in a regulated industry with applied experience/knowledge in regulatory (preferred), quality or similar position.
Ability to execute assignments independently as assigned. Must possess strong organizational skills. Must possess strong written and verbal communication skills. Must possess demonstrated ability to handle multiple priorities simultaneously. Proficient in Microsoft Office Products.
Knowledge of 21 CFR 820, EU MDD/MDR, ISO 13485, and ISO 14971 (desired)
Internal Number: 280
Diversatek, Inc. is a global, multi-platform healthcare solutions manufacturing company. Invested in a broad and ever-growing line of medical technologies, Diversatek manufactures and markets products and solutions for diagnostic and therapeutic procedures, continuing care and rehabilitation, and medical device OEMs. Diversatek owns and operates manufacturing facilities in Wisconsin, Colorado, Virginia, and Saigon, Vietnam. Our Technical Research and Training Center in Denver, CO boasts a best-in-class clinical education and product training center for healthcare providers worldwide.