Senior Regulatory Affairs Specialist en Gurugram a Stryker Corporation

Fecha de publicación: 10/28/2019

Resumen de la oferta

Descripción del empleo

Who we want:

  • Sets direction:  An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.
  • Builds organizational capability:  A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.
  • Inspires others:  A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.
  • Champions talent development:  A manager who focuses on maximizing the ability, potential and contributions of themselves and others.   Fosters an environment where people can excel through developing, coaching and rewarding performance.
  • Delivers results:  A driven player/coach who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks.

What you will do:

  • Performing the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies
  • Carrying out internal audits and inspections
  • Compiles all materials required in submissions, license renewal and annual registrations.
  • Recommending changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
  • Monitoring and improving tracking/control systems.
  •  Keeping abreast of regulatory procedures and changes.

What you will need:

  • Bachelor’s /Master’s Degree in Mechanical Engineering
  • Minimum of 5-8 years’ experience with medical devices sold in the EU/US
  • Strong working knowledge of EU regulations including experience with developing and preparing submissions for EU Notified Bodies (Technical Files and Design Dossiers)
  • Knowledge/Working experience on US FDA/China NPMA is preferred
  • Experience with orthopedic devices is preferred
  • Prior experience collaborating in cross-functional development teams providing feedback as the RA representative
  • Prior experience working on new EU Medical Device Regulation implementation projects and/or large enterprise projects desired
  • Knowledge on ISO 14971/ISO 10993 standards

Work From Home: Yes

Travel Percentage: None

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