Compliance and Regulatory Expert EEMEA

5 days ago


Riyad Al Khabra, Saudi Arabia Stryker EMEA Supply Chain Services B.V Full time
Requirements:

To be successful in this role, you will need:

  • A BSc degree in a relevant field. An advanced degree is preferred, and RAC certification is also desirable.
  • No less than 8 years' experience, with 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, as well as other international requirements pertaining to the medical device industry.
  • 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.
  • Undertaking assignments that are broad in nature, requiring originality and ingenuity.
  • Ability to take unreviewed action or decisions.
  • Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions, and third-party distributors.
  • Leads meetings with regulatory agencies, internal and external audits, and other stakeholders, with minimal support.
  • Prepares briefings and other information documents.
  • Communicates information and advises on RA/QA/PMS requirements to other departments and business units.
  • Engages in communication with regulators and other key stakeholders on routine and complex matters with minimal supervision.
  • Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization.
  • Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
  • Connects and relates well with people who think and act differently than oneself.
  • Embraces scrutiny and accepts feedback as an opportunity to learn and improve.
  • Preparation of 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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