Trwa ładowanie. Prosimy o chwilę cierpliwości.
Przeglądana oferta pracy jest nieaktualna
Data aktualizacji: 2024-06-19
Warszawa, mazowieckie
Audyt, BPO/SSC
Praca hybrydowa
Data aktualizacji: 2024-06-19

Oferta pracy jest nieaktualna

Pracodawca zakończył rekrutację na to ogłoszenie

Podobne oferty pracy

Capgemini Polska
Poznań, Gdańsk, Katowice, Wrocław, Lublin, Warszawa, Kraków, Opole
Senior Regulatory Affairs and Quality Assurance Specialist

Senior Regulatory Affairs and Quality Assurance Specialist


We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
As a Senior Regulatory Affairs and Quality Assurance Specialist you will be part of the Regulatory Affairs and Quality Assurance (RAQA) team supporting Middle East and North Africa (MENA) :

What you will do:

  • Executes RA activities in line with defined procedures and processes.
  • Obtain product registration dossiers from EMEA Central RA and tailor them to meet country registration requirements
  • Communicate with Stryker consultants and distributors across MEA to track and ensure timely dossier submission to the relevant authority
  • Assist Stryker Customer Service team and local dealers in preparing country specific regulatory documentation for custom clearance in MEA (Middle East and Africa) region
  • Create and maintain registration database for MEA countries.
  • Implements processes involved with maintaining annual licenses, registrations, and listings
  • Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
  • Assesses regulatory intelligence to assist in the development of local and regional, regulatory strategies
  • Evaluates the country/region regulatory environment and contributes to providing internal advice throughout the product lifecycle to ensure product compliance
  • Report regulatory obstacles and emerging issues throughout the product lifecycle and propose solutions
  • Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
  • Provide on the job training for new team members and delivers training to stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Performs based on established targets, KPIs and objectives for RAQA.
  • Provides support to EMEA / Country RAQA teams as appropriate.

What you need:

  • Bachelor's/Master's degree
  • Minimum 2 years experience in Regulatory Affairs
  • Experience in Medical Device preferred
  • Pharmaceutical industry experience desired
  • Fluent in English
  • Strong IT skills, including Microsoft Office.
  • Ability to connect and relate well with people
  • Be active in preparation of briefings and other information documents.
  • Accountable for local process and training implementation
  • High attention to detail and process consciousness

Limited travel required to Stryker Dubai site or other Stryker sites for meetings.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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Capgemini Polska
Poznań, Gdańsk, Katowice, Wrocław, Lublin, Warszawa, Kraków, Opole