Regulatory Technical File Specialist for Devices and Equipment

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Job Number: 4338

External Description: A career at Merck is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Job Title:Regulatory Technical File Specialist for Devices and Equipment

Location: Bangalore

We are currently seeking a Regulatory Technical Files Specialist for Devices and Equipment - based in Bangalore, India.

You will act as a Regulatory Specialist for the Technical Files for the Devices and Equipment team of the Life Science business sector to support technical writing, technical file publishing, and IVD & Equipment trade compliance activities. You work with the dedicated document management and e-submission system ELDORADO. You support the regulatory team at the manufacturing sites with technical writing of technical file documents for Merck Life Science products such as IVDs and Equipment. You verify IVD and Equipment customers to hold Marketing and Importation authorizations to ensure trade compliance of shipments to eligible customers. You respond to regulatory customer inquiries related to mature products and existing country registrations and interact with Quality Services.

You work in a global regulatory team and collaborate closely with the regulatory experts at the manufacturing sites and in the regions.

Roles & Responsibilities:

  • Publish of regulatory technical files with the document management and e-submission system ELDORADO,
  • Support technical writing of regulatory dossier documents for Devices and Equipment in ELDORADO, based on technical procedures or reports,
  • Authorize customers to refer to our product registrations, obtain Export Certificates or other documents required to register products.
  • Provide regulatory customer support for mature Devices and Equipment for already existing country registrations.
  • Verify customers to obtain a marketing or importation authorization.


Qualification, Skills & Experience:
  • Master level of education in life sciences or engineering with a strong emphasis in chemistry, biology.
  • relevant industry experience and/or regulatory affairs related to medical devices and equipment, specifically electrical and wifi regulations.
  • Knowledgeable of the regulatory processes in the US FDA and EU, including drug, medical device & equipment regulations. Ideally with knowledge of regulatory processes in China, India and of other countries in Asia, as well as Brazil, Mexico and other Latin American countries.
  • Experience in submissions in CTD format. Experience in e-submission tools is welcome.
  • Knowledge of regulations relevant to medical devices and equipment, quality requirements and preferably processing of Devices and Equipment in general.
  • Business-fluent English skills.
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems such as Oracle or SAP. Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.


What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com

Job Number: 179910

Community / Marketing Title: Regulatory Technical File Specialist for Devices and Equipment

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