hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Regulatory Operations Specialist

3.00 to 5.00 Years   Pune   31 Mar, 2021
Philips
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

provide strategic input during product creation process and supports in developing the department s overall regulatory strategy plan. At IGT-S this role cooperates closely with Product Development, Medical / Clinical Affairs and Marketing and Sales. We are looking for a regulatory affairs expert that has experience with submission of medical devices(FDA, Health Canada, EU, etc.) and is looking for a challenge in coaching her/his RA project team members next to leading in the difference regulatory affair activities like new project introductions, maintenance projects and process improvements.You are responsible for

  • Work according the business applicable processes and as ambassador of the Philips values.
  • Train regulatory resources in their development.
  • Exercise supervision in terms of schedules, methods and staffing for projects leading
  • Establishes operational objectives and work plans, and delegates assignments to project team members.
  • Keeps abreast of current regulatory procedures and changes
  • Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
  • (support)Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance.
  • Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape , regulatory/ legislative initiatives, and product marketing strategy for their responsible products within IGT-S Fixed portfolio
  • Responsible for product registrations/approvals in her/his field.
  • Leads regulatory resources as part of projects (s)he works in.
You are a part ofYou will be a team member of the global Philips regulatory organization and will be reporting to the India Regulatory leader for Image Guided Therapy Systems (IGT-S). The team you will be working in, is a high-performance, culturally diverse, and very dynamic team. It consists of 35 people working in the areas, divided over India and the Netherlands.To succeed in this role, you should have the following skills and experience
  • Minimal of 8 years of experience in the medical device industry and technical environment with at least 3 years in an Imaging Diagnostic medical device company( FDA Class II equivalent Class III a plus)
  • Must have experience with successful preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide
  • Strong background in Design Controls
  • Excellent working knowledge of Standards like IEC62304/82304/60601
  • Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
  • Experience in supporting international registrations and clinical investigations(as a plus)
  • Approx. 5% travel annually with some international.
  • Bachelor s degree in a technical/quality/law/pharma discipline
  • RAPS certified(as a plus)
In return, we offer you
  • A rewarding career in Philips with attractive package.
  • Extensive set of tools to drive your career, such as a personal development budget, training and coaching
  • Attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount
,

Keyskills :
qualityproduct marketingmedical devicescustomer serviceregulatory affairsclass iisaleshealth insurancecustomer relationsreportinginternal audit

APPLY NOW

Regulatory Operations Specialist Related Jobs

© 2019 Hireejobs All Rights Reserved