This position is responsible for the support of regulatory submissions required to market medical devices in the U.S., Europe and other international markets and sustaining-engineering related regulatory affairs activities for BD Medical - Medical Delivery Solutions (MDS). Requires the analysis of data, problem solving and evaluations of various factors.
Assess necessity for submitting a 510(k) application for proposed device changes.
Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Submit notification to the Notified Body about significant changes to CE marked products in a timely manner.
Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary
Support International Registrations as it relates to product changes and/or new product launches Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis. Create and maintain regualtory performance metrics. Identify opportunities to improve the existing process and implement the improvements.
Work with Regulatory Project Manager to execute large scale projects, e.g. euMDR, MDSAP, etc.
Carry out the above tasks with limited supervision.
Education
B.S. degree or higher in a life science or technical discipline, preferably in biology, or chemistry, engineering, bioengineering and regulatory affairs.
Licenses/Certifications
RAPS Certification is a plus
Experience
5-7 years regulatory affairs experience in medical device regulations 2. Understanding of US, EU and international medical device regulatory requirements
Special Skills
Proficient in using various computer programs.
Strong oral and written communication skills 3. Project management skills.
Handle multiple tasks and prioritization skills.
Attention to details.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x