Director, Regulatory Affairs and Quality Assurance
OuraFull Time
Expert & Leadership (9+ years)
Candidates must possess a BSc degree in a relevant field, with an advanced degree or Master's degree being preferred, and RAC certification is desired. A minimum of 10 years of experience is required, including over 5 years of supervisory experience. Demonstrated project management, time management, coordination, and execution skills for complex RA/QA/PMS items are essential. Proficient knowledge of regulatory requirements, including the Medical Device Directive, EU Medical Device Regulations, Quality System, Post Market Surveillance, and other international medical device regulations, is necessary. The role also requires demonstrated technical knowledge of medical device regulatory and quality requirements, the ability to effectively prioritize and manage multiple project workloads, and proven leadership skills in employee development and team building. Experience with recruiting, hiring, and developing talent, along with process improvement skills, is also required. The candidate must be able to manage complex, multi-region projects in a matrix environment and collaborate effectively with cross-functional teams, demonstrating influence across the organization.
The Sr Manager, RAQA will apply expert knowledge of RA/QA/PMS frameworks and legislative requirements within the EMEA distribution organization, directing initiatives related to good regulatory practice and policy. Key activities include collecting and maintaining RAQA intelligence, identifying and implementing new regulatory procedures and SOPs, and supporting continuous improvement across RAQA. The role involves performing based on established RAQA targets, KPIs, and objectives, leading EMEA/Country RAQA teams, monitoring team performance, and providing coaching and feedback for high performance. Responsibilities also include setting performance objectives, acting as the RAQA Leader reporting performance, risks, and issues to leadership teams, and serving as a subject matter expert to the local business. The manager will lead teams to support regulatory processes for market access, develop and deploy new systems and procedures, and lead Third Party, Competent Authority, or Notified Body audits. They will also support continuous improvement activities, define RAQA targets and KPIs, lead talent acquisition and development, and foster team engagement and collaboration. Integration of new acquisitions, ensuring RAQA systems integration, and representing Stryker in local industry associations for advocacy activities are also key duties. The role requires coordinating, supporting, and leading technical and scientific RA/QA/PMS activities, undertaking assignments requiring originality and ingenuity, and taking unreviewed action or decisions on business-critical matters.
Develops and manufactures medical devices and equipment
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.