Senior Regulatory Affairs and Quality Assurance Specialist

2 tygodni temu

Warszawa, Mazovia, Polska Stryker Pełny etat

Are you looking for a career opportunity at a renowned company where you can engage in diverse projects and collaborate across various functions? Joining Stryker's Regulatory Affairs/Quality Assurance (RAQA) team offers you continuous learning prospects and ample room for professional growth. If you seek to be a part of a globally recognized workplace, take your chance here.

Need more reasons to consider this role? Here are 10 compelling benefits of being part of the Regulatory Affairs/Quality Assurance team:

What you will do:

  • Execute RA activities following established procedures and processes.
  • Handle product registration dossiers from EMEA Central RA, customizing them to meet country-specific requirements.
  • Collaborate with Stryker consultants and distributors across MEA to facilitate timely dossier submissions to relevant authorities.
  • Assist Stryker Customer Service and local dealers in preparing regulatory documentation for custom clearance in the MEA region.
  • Establish and maintain a registration database for MEA countries.
  • Manage processes related to maintaining annual licenses, registrations, and listings.
  • Submit notifiable changes and supplemental dossiers to regulatory authorities for product information updates.
  • Stay informed about regulatory changes to aid in local and regional regulatory strategy development.
  • Evaluate regulatory landscapes and offer guidance on product compliance throughout the lifecycle.
  • Identify regulatory challenges and propose effective solutions.
  • Suggest and contribute to developing new regulatory procedures and SOPs.
  • Provide on-the-job training and deliver regulatory requirement training to stakeholders.
  • Work towards established targets, KPIs, and RAQA objectives.
  • Offer support to EMEA/Country RAQA teams as needed.

What you need:

  • Bachelor's/Master's degree.
  • Minimum of 2 years of experience in Regulatory Affairs.
  • Preferably, experience in the Medical Device sector.
  • Pharmaceutical industry experience is a plus.
  • Proficiency in English.
  • Strong IT skills, particularly in Microsoft Office.
  • Excellent interpersonal skills and the ability to communicate effectively.
  • Accountable for local process and training implementation.
  • Detail-oriented and process-driven.

Limited travel may be necessary to Stryker's Dubai site or other company locations for meetings.

About Stryker: Stryker stands as a pioneer in medical technologies, committed to enhancing healthcare outcomes in collaboration with its partners. The company provides cutting-edge products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine, impacting over 130 million patients globally each year.

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