Senior Regulatory Affairs and Quality Assurance Specialist

Work Flexibility: Hybrid<p></p><p></p><p>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) :</p><p><br/><u>What you will do : </u></p><ul><li><p>Executes RA activities in line with defined procedures and processes.</p></li><li><p>Obtain product registration dossiers from EMEA Central RA and tailor them to meet country registration requirements</p></li><li><p>Communicate with Stryker consultants and distributors across MEA to track and ensure timely dossier submission to the relevant authority</p></li><li><p>Assist Stryker Customer Service team and local dealers in preparing country specific regulatory documentation for custom clearance in MEA (Middle East and Africa) region</p></li><li><p>Create and maintain registration database for MEA countries.</p></li><li><p>Implements processes involved with maintaining annual licenses, registrations, and listings</p></li><li><p>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</p></li><li><p>Assesses regulatory intelligence to assist in the development of local and regional, regulatory strategies</p></li><li><p>Evaluates the country/region regulatory environment and contributes to providing internal advice throughout the product lifecycle to ensure product compliance</p></li><li><p>Report regulatory obstacles and emerging issues throughout the product lifecycle and propose solutions</p></li><li><p>Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation</p></li><li><p>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</p></li><li><p>Performs based on established targets, KPIs and objectives for RAQA.</p></li><li><p>Provides support to EMEA / Country RAQA teams as appropriate.</p></li></ul><p></p><p><u>What you need :</u></p><ul><li><p>Bachelor's/Master's degree</p></li><li><p>Minimum 2 years experience in Regulatory Affairs</p></li><li><p>Experience in Medical Device preferred</p></li><li><p>Pharmaceutical industry experience desired</p></li><li><p>Fluent in English</p></li><li><p>Strong IT skills, including Microsoft Office.</p></li><li><p>Ability to connect and relate well with people</p></li><li><p>Be active in preparation of briefings and other information documents.</p></li><li><p>Accountable for local process and training implementation</p></li><li><p>High attention to detail and process consciousness</p></li></ul><p><br/><u>Limited travel required to Stryker Dubai site or other Stryker sites for meetings.</u></p><p></p><p></p>Travel Percentage: 20%<p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p>