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Applies expert knowledge and understanding of the RA / QA / PMS frameworks,
legislative requirements, processes and procedures in the EMEA distribution
organisation. Direct and contribute to initiatives within the organization with groups
engaged in the development of good regulatory practice and policy.
Key Activities & Accountabilities
* Customized according to RA / QA / PMS pillars and country-specific responsibilities.
* Collects, organizes, and maintains files on local, regional, and global RAQA intelligence.
* Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
* Supports continuous improvement activities across RAQA.
* Performs based on established targets, KPIs, and objectives for RAQA.
* Leads EMEA / Country RAQA teams as appropriate.
* Monitors team performance and provides coaching and feedback.
* Ensures high team performance aligned with company values.
* Sets performance objectives and milestones for goal achievement.
* Acts as RAQA Leader, reporting to local and other leadership teams.
* Serves as a subject matter expert to the local business.
* Leads regulatory processes for market access of products.
* Develops and deploys new systems and procedures locally.
* Leads audits with Third Parties, Competent Authorities, or Notified Bodies.
* Supports continuous improvement activities within RA, QA, and PMS.
* Defines targets, KPIs, for RAQA in the local office.
* Leads recruiting, onboarding, and talent development.
* Maintains high team engagement and collaboration.
* Leads integration of new acquisitions into RAQA systems.
* Represents Stryker in local industry associations as RAQA expert.
* Coordinates with manufacturing and Design Divisions for support.
Education
BSc degree in relevant field. Advanced Degree preferred.
Master's Degree or equivalent desired.
RAC preferred.
Experience
10 years’ experience, including 5+ years supervisory.
* Project management and coordination of complex RA / QA / PMS tasks.
* Knowledge of Medical Device Directive, EU MDR, QMS, PMS, and international requirements.
* Technical knowledge of medical device regulatory and quality standards.
* Ability to prioritize and manage multiple projects.
* Leadership and employee development skills.
* Experience with recruiting and talent development.
* Process improvement skills.
* Ability to manage multi-region projects in a matrix environment.
* Effective collaboration and leadership of cross-functional teams.
* Influence across the organization.
* Support and lead technical RA / QA / PMS activities.
* Ability to handle broad assignments requiring originality.
* Decisiveness on business-critical matters.
* Effective communication with stakeholders at all levels.
* Leadership in audits, briefings, and regulatory communications.
* Develops solutions amid complexity and fosters diverse ideas.
* Engages with regulators and key stakeholders routinely.
* Prepares metrics and reports for RA / QA / PMS.
* High attention to detail and process consciousness.
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