European Medical Device Regulation Specialist

hace 2 días


San Agustín del Guadalix, Madrid, España Bd, Becton And Dickinson A tiempo completo

About the Company

Bd, Becton And Dickinson, is one of the largest global medical technology companies in the world. Our Purpose is to Advance the World of Health. We are the makers of possible.

Job Description

We are seeking a highly skilled Senior Counsel, Regulatory Law EMEA to join our team. As a member of the EMEA Law Group, you will report to Chief Regional Counsel EMEA and provide regulatory law advice and counsel on a wide range of matters.

The successful candidate will be a European based attorney with at least 5 years of relevant experience in regulatory and/or trade law. You will maintain knowledge of current medical device and drug regulatory law, pending legislative and regulatory changes, and enforcement actions.

Responsibilities

  1. Provide expert advice and counsel to supported businesses concerning complex regulatory matters with a focus on MDR/IVDR and medical device regulations in the EMEA region.
  2. Advise on legal issues throughout the medical device life cycle related to recalls, promotion and advertising, clinical studies, medical device reporting, drug adverse event reporting, corrections and removals, product clearance and approvals, inspections, and quality system compliance.
  3. Maintain knowledge of current medical device and drug regulatory law, pending legislative and regulatory changes, and enforcement actions to maintain the highest level of expertise.

Requirements

  1. Master degree from an accredited law school. Licensed to practice law in an EU member state.
  2. At least 5 years of relevant experience in regulatory and/or trade law.
  3. Working knowledge of EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) and experience advising clients on U.S. and/or EU medical device regulatory law is required.

Benefits

We offer a competitive salary package, including benefits such as health insurance, retirement plan, and paid time off.



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