Responsible for providing Regulatory Affairs support under direct supervision supporting regulatory authorizations to market medical device products in global markets. This position requires the incumbent to work under the direct supervision of senior regulatory professionals in the collection and collation of materials required for various country submissions. May provide preliminary review of product technical information, certification documentation, master file documents. Position may support facility inspections and participate in other regulatory support activities as required.
The position acts as a liaison between product development teams and global regulatory agencies to communicate technical product design for product approvals through participation in preparation of product submissions and license renewals, and daily maintenance of business issues.
US submissions and support of Non-US product submissions (new registrations, renewals, technical files) based on input from RA Managers and Regional Regulatory groups.
•Research engineering standards and medical device regulations.
•Support RA Managers in interactions with FDA and international government agencies with product approval issues.
•Support/participate in Regulatory projects.
•Participate as required in audits of B&L facilities.
•Conduct FOI requests.
•Support Sales, Customer Service groups and customers by providing regulatory documentation required for bids and customs issues and product material/sterilization requests.
•Assist in providing applicable regulatory information to support import/export applications.
•Ensure records related to product approvals and licenses are accurate and maintained according to departmental requirements.
•Administrative Functions as needed
• Other job responsibilities as needed
•BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law.
•Minimum 2 years’ experience in Regulatory Affairs for Medical Devices with a demonstrated capability and experience preparing submissions for US Class II/Class III medical devices. Knowledge of medical device or drug GMP's required.
•Experience preparing non-US medical device registrations highly desired.
•Knowledge of U.S. FDA medical device regulations and guidance documents.
•Must have excellent communication, organization, time management and writing skills.
•Strong interpersonal skills required in areas of verbal and written communications, service to internal customers, and professionalism.
•Strong questioning and problem-solving skills.
•Must be self-motivated by working independently and having the ability to take ownership of his/her responsibilities.
•Must have command of English language.
•Computer literate with general office software and internet use.
•Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures.
• Ability to write routine reports and business correspondence