Senior Regulatory Affairs and Quality Assurance Specialist

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%