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Senior Regulatory Engineer RA

2.00 to 4.00 Years   Bangalore   24 Mar, 2021
Philips
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

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  • The Regulatory Affairs Specialist works mostly with countries all over the world on the International registrations and support in special actions like CAPAs. This can be a person who is looking to get a better understanding how Regulatory works in the international market(outside of EU, USA, Canada and Japan).
You are responsible for
  • Work according the business applicable processes and as ambassador of the Philips values.
  • Works with the RA Project Leads/RA Seniors to get the required information to get clearances for the products that are changed or released towards the markets.
  • Takes lead for RA CAPAs and support the RA team to close CAPAs
  • Support development of the regulatory plan, guidance on risk assessment, and required corrective action to meet regulatory requirements and product registrations such as, but not limited to , CE marking and clinical evaluations.
  • Develops and facilitates regulatory submissions, for new product/solutions existing products/solutions in the international markets.
You are a part ofYou will be a team member of the global Philips regulatory organization and will be reporting to the India (Bangalore) 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
  • Bachelor s degree in a technical/quality/law/pharma discipline
  • 2-4 years of experience in the medical device industry
  • Goal oriented, reliable, and extremely well organized with strong attention to detail.
  • Demonstrates ability to work independently and work through projects with minimal supervision.
  • Affinity with medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations is a plus.
  • Familiarity with preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide is a plus
,

Keyskills :
capasrisktherapyregulatory affairsmedical devicesregulatory requirementsregulatory submissionscorrective actionclinicalmarketingce markingmarkingbusinessrisk assessmentfdamedicalphilips

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