Medtronic is hiring B. Pharma/ M. Pharma as a Regulatory Affairs Specialist-II – Apply Now

0
84
WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now
Exciting news for pharmaceutical professionals! Medtronic, a global leader in medical technology, is actively seeking candidates with B. Pharma or M. Pharma qualifications to join their esteemed team as Regulatory Affairs Specialist-II. This opportunity marks a significant milestone for individuals aspiring to make impactful contributions in regulatory affairs within a renowned healthcare organization.

Job Title: Regulatory Affairs Specialist-II

Qualification: B. Pharma/ M. Pharma

Experience: 2 to 7 Years

Responsibility

Responsible for implementation of regulatory compliance systems and support Regulatory Affairs activities of India Medtronic. He/she participates in all activities relating to preparation, submission and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices of various business units of Medtronic. He/ she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures.

Job Roles

  • Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in India.
  • Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in India.
    Submit and track registration/re-registration applications with the authorities.
    Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
  • Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).
  • Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
  • Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.
  • Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.
  • Supporting the Marketing Teams on Tender related issues
  • Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP’s, archival, trackers and systems) within the department and organization.
  • Interface and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.
  • Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the India.

Must Have Minimum Requirements

  • B Pharma / M Pharma / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
  • Must have at least 5-7 years’ experience in the pharma/medical device/life science industry with at least 2-3 years’ medical device experience in regulatory affairs
  • Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.
  • Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release

Key Skills

  • Excellent communication and interpersonal skills – Good verbal communicator and presenter
  • Customer focused: Understands and delivers customer service
  • Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
  • Good verbal and written communication skills in English – with colleagues, management and external authorities
  • Self-motivated and positive “Can do” attitude. Can work autonomously but is also a team player
  • Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn
  • Be able to plan, manage, organize and report in an efficient way
  • Be independent, persuasive, innovative and able to summarize
  • Good time management: Well organized, able to set and reset priorities
Job Location Gurgaon
ID 23000JFW
Apply Online Click Here

 

<<<<<<<<<<<<MORE JOBS>>>>>>>>>>>>>>

Walk-In Interview for B. Pharma as a Production Supervisor at Tirumala Tirupati Devasthanams, AP More Info..
Pharmacist Vacancy at District health Society (DHS) Surat More Info..
Research Opportunity as a ICMR Funded Senior Research Fellow at AIIMS Delhi More Info..
Join ECHS Polyclinic Varanasi Cantt as a Pharmacist – Apply Now More Info..
Career Opportunity as a Scientific Assistant ‘B’ (Radiodiagnosis) at HBCHRC Vizag More Info..
Recruitment of Pharmacist (06 Posts) at ECHS Polyclinic Ambala Cantt More Info..
Join Indian Air Force as a Airmen in Group Y Medical Assistant Trade – D. Pharma/ B. Sc. in Pharmacy can apply More Info..

<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>

Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here
Follow us on Instagram Click Here
Download PHARMACY INDIA MOBILE APP from Google Play Store  Click Here
Follow us on LinkedIn Click Here

 

LEAVE A REPLY

Please enter your comment!
Please enter your name here