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

Who we want:

• Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partners
• Collaborative Partners. Relationship-savvy people who intentionally make connections, listen to others' ideas and work together to move the business forward.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations

• Provide expert chemistry technical input to the manufacturing and analytical testing functions, acting as champion for implementation of industry best practice, standards and regulations in chemistry and related areas
• Provide innovative, quality focussed technical input and solutions into NC/CAPA resolution. Deliver Technical Assessments to support SofHA rationale.
• Assess cost-saving opportunities, provide innovative solutions for business while maintaining focus on compliance, ensuring implementation of industry best practice and new technology.
• Participate/ Lead in cross functional / site project/investigation teams as required and have ability to successfully communicate complex technical content.
• Design and provide technical training and education for the business as required, in areas of expertise. Mentors and trains team and cross functional groups as required.
• Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
• Calloborate with the global Stryker team where applicable in providing innovative consolidation solutions. Participate in relevant forums/conferences.
• Support as needed in all regulatory audit preparation.
• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
• Support of, ensure compliance of new products to sites' chemistry standards. Ensure successful integration of products into validated processes.
• Demonstrate technical supervisiory capabilities and leads projects to completion
• Demonstrates knowledge of the business processes and products across multiples sites.
• Deputises for the Chemistry Laboratory Team Leader / Associate Manager in their absence.

• Bachelor degree/ Masters Chemistry or related subject or equivalent
• and
• 4 years chemistry related experience.
• Minimum of 5 years in regulated environment.
• Advanced knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Chemistry)
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
• Strong analytical skills in both Inorganic and Organic chemistry.
• Experience in working in a compliance risk situation.
• High proficiency in statistical techniques, data review and analysis.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
• Some travel may be required.