Job Description Summary
The Senior Regulatory Affairs Specialist will ensure that BD fulfils the responsibilities and activities of BD as European Authorised Representative (EAR), as Swiss Authorised Representative (CH-Rep) and UK Responsible Person (UK-RP).
The role will also support the wider EMEA regulatory affairs team as required.
About Us
We are the makers of possible BD is one of the largest global medical technology companies in the world.
Advancing the world of health is our Purpose, and it's no small feat.
It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Our Vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BD's innovative medical technologies by having an acutely patient-centric mindset.
About the Role
The Senior Regulatory Affairs Specialist at BD is responsible for ensuring the company meets its obligations as the European Authorised Representative (EAR), Swiss Authorised Representative (CH-Rep), and UK Responsible Person (UK-RP).
This includes obtaining and maintaining mandates with manufacturers, reviewing technical documentation, creating and submitting registration packages, and ensuring compliance with relevant regulatory requirements.
Main Responsibilities:
* Ensure the responsibilities of BD as EAR, CH-Rep and UK-RP are met.
* Obtain and maintain AR mandates with each of the applicable manufacturers.
* Obtain and review technical documentation to ensure it meets the AR obligations.
* Create, submit and maintain dossiers and submission packages to meet the registration obligations of the AR.
* Perform impact assessments.
* Prepare, review and submit derogations.
* Provide support to AR audits.
* Obtain free sale certificates to support the global market.
* Liaise with internal and/or external customers as appropriate to promptly resolve customer, Notified Body and regulatory agency queries.
* Maintain regulatory databases/systems for key regulatory data.
About You
Excellent Communication Skills
Can Do Attitude
Strategic Way of thinking and Hands On
5+ Years of Experience working in a Highly Regulated Environment (Medical Devices or Pharma)