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Regulatory Affairs Manager

2 months ago

Dubai, Dubai, United Arab Emirates Stryker Corporation Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Stryker Corporation. As a key member of our Regulatory and Quality Affairs (RAQA) team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to improve our quality management systems.

Key Responsibilities
  • Develop and implement comprehensive knowledge of regulatory frameworks, legislative requirements, and quality management processes.
  • Collect, organize, and maintain files on local, regional, and global RAQA intelligence.
  • Identify opportunities for continuous improvement and support activities across RAQA.
  • Lead teams to support regulatory processes for market access of products.
  • Develop and deploy new systems and procedures locally.
  • Lead Third Party, Competent Authority or Notified Body audits within the local organization.
  • Support continuous improvement activities across RA, QA, and PMS activities within the local office.
  • Define targets, KPIs, and performance objectives for RAQA within the local office.
  • Lead recruiting, selection, on-boarding, and development of talent within the local office to increase performance.
  • Maintain a high level of team engagement and collaboration across the RAQA team in the local office.
  • Monitor team performance and take action to keep the team on track by providing coaching and feedback to others.
Requirements
  • BSc degree in a relevant field. Advanced degree preferred.
  • RAC preferred.
  • 8 years' experience. 3+ years supervisory experience.
  • Project management and time management skills, writing, coordination, and execution of complex RA/QA/PMS items.
  • Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System, and Post Market Surveillance requirements.
  • Demonstrated ability to effectively prioritize and manage multiple project workloads.
  • Demonstrated ability to lead and develop employees and build effective teams.
  • Demonstrated leadership skills.
  • Experience with recruiting, hiring, and developing talent.
  • Demonstrated process improvement skills.
  • Demonstrated ability to manage complex and multi-region projects within a matrix environment.
  • Demonstrated ability to collaborate effectively with and lead cross-functional teams.
  • Influence across the organization.
  • Coordinate, support, and lead technical and scientific RA/QA/PMS activities.
  • Undertake assignments that are broad in nature, requiring originality and ingenuity.
  • Ability to take unreviewed action or decisions.
  • Clearly convey information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions, and third-party distributors.
  • Lead meetings with regulatory agencies, internal and external audits, and other stakeholders, with minimal support.
  • Prepare briefings and other information documents.
  • Communicate information and advise on RA/QA/PMS requirements to other departments and business units.
  • Engage in communication with regulators and other key stakeholders on routine and complex matters with minimal supervision.
  • Create clarity and direction amid complexity and develop solutions for self, colleagues, and the organization.
  • Seek out diverse ideas, opinions, and insights, and apply them in the workplace.
  • Connect and relate well with people who think and act differently than oneself.
  • Embrace scrutiny and accept feedback as an opportunity to learn and improve.
  • Prepare RA/QA/PMS metrics for reporting purposes.
  • High attention to detail and process consciousness.
  • Fluent in English (Arabic language skills are a plus).

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