Job Description

Join to apply for the Regulatory Affairs Associate role at BD (Tissuemed Ltd) 3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Job Description Summary The Regulatory Affairs (RA) Associate is an entry-level role for the RA Professional. The Associate will provide regulatory support for one or more product lines and/or region(s), including participation on new product development teams and continued support through the lifecycle of the product. The Associate may also help to prepare regulatory submissions required to market new or modified medical devices in global markets. The Associate is able to communicate regulatory issues to management to ensure the business is aware of opportunities, risks and concerns. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. Responsibilities Reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed. Participates in core teams and provides guidance on regulatory requirements to product development teams, with guidance/support from management. Supports preparation of dossiers and submission packages for regulatory agencies. Supports strategic regulatory activities of a more senior RA team member. Reviews advertising and promotional material for respective product line(s) and/or regions(s) as needed. Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s) as needed. May participate in regulatory body audits in a supporting role. Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends. Completes day-to-day support for RA Systems. Ability to travel up to 25% of the time. Minimum Requirements Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field, or equivalent combination of related education and experience. Preferred Requirements Previous experience in the medical device industry. Previous regulatory affairs experience, e.g., RA Internship. Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy. Ability to complete assigned work with minimal supervision and ability to work independently. Ability to plan and schedule multiple priorities in a concurrent fashion. Ability to review, collate and summarize scientific and technical data. Ability to learn new technical concepts. Excellent writing and strong organizational skills. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To learn more about BD, visit Equal Opportunity Employer Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #J-18808-Ljbffr BD (Tissuemed Ltd)

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