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Senior Regulatory Affairs Specialist

Becton Dickinson
Job LocationWinnersh
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Here at BD we have an excellent opportunity for an individual to join us in an International Regulatory Affairs role. In this leading medical devices Corporation, you will be able to build upon your professional knowledge of global market clearance procedures as well as of active (electro-medical) and disposable standards compliance. The function is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards.The individual has to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations, also identifying, preparing and collecting data needed to obtain and maintain certifications and commercialization authorizations of BD products.

  • Participation in cross-functional product development teams as the regulatory lead
  • Development of regulatory strategies for product release and product change assessments
  • Participate to the review of process/product changes, labeling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International requirements;
  • Attends to audits performed by internal and external authorities to represent RA positions and processes;
  • Execute transition of MDD tech files to MDR Technical Documents, monitor and report progress
  • OUS international product registrations attending to individual country specific requirements; monitor and report progress
  • Assesses changes in regulations and helps to determine their impact;
  • Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle
    • You must have proven regulatory affairs experience within the medical technology industry or equivalent. You should have demonstrated compliance experience with Class I/IIa/IIb MDD/MDR medical devices, possibly including (P)EMS - (Programmable) Electrical Medical Systems;
  • Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking;
  • Experience working with International Standards in particular IEC/EN 60601-1 (safety)/ 60601-1-2 (EMC)/ 62304(software)/ 62366(usability), ISO 14971 and ISO 13485;
  • Good working knowledge of Design Control, Software Life Cycle, Risk Mgmt, V&V processes;
  • Prior work experience on MDR preferred
  • Solid knowledge and material experience in International registrations/ approval process for medical devices
    • You should be an enthusiastic teammate, able to participate with commitment and sense of ownership in highly qualified teams, in a complex and fast evolving environment. With Strong knowledge in international standards and regulations including MDR, IEC/EN60601-1, EN62304, EN62366, ISO13485, ISO14971 and Medical Devices Directives.Sound like you Then click the APPLY button to proceed! Required skills
  • Compliance
  • Medical Devices
  • Regulatory Affairs
  • IEC/EN 60601-1

    • Keyskills :
    Compliance Medical Devices Regulaty Affairs IEC/EN 60601-1

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