Job Information
Stryker Senior Regulatory Affairs and Quality Assurance Specialist in Warsaw, Poland
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: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-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 Stryker
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 130 million patients annually. More information is available at stryker.com. (http:)
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.