Senior Regulatory Affairs and Quality Assurance Specialist

4 tygodni temu


Warsaw, Polska Stryker Pełny etat

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World’s Best Workplaces, apply now

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: 

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.

About StrykerStryker 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 130 million patients annually. More information is available at 



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