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Senior Regulatory Affairs and Quality Assurance Specialist

3 miesięcy temu

Warszawa, Polska Stryker Polska Sp.z o.o. Pełny etat
Work Flexibility: Hybrid

We are looking for a Senior Regulatory Affairs and Quality Assurance Specialist in Poland for a contract until the end of 2025. Based in Poland (Hybrid), you will be part of the 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 :

Minimum 2 years experience in Regulatory Affaires

Bachelor's/Master's degree

Experience in Medical Device or Pharmaceutical industry 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.

Travel Percentage: 20%