Sr Compliance Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

Responsibilities may include the following and other duties may be assigned.

• Own and drive Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions
• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements
• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with Medtronic policies and global regulatory requirements.
• Supporting the EU Surgical Operating Unit entities from a Quality Oversight perspective consisting of pro-active support (example helping, supporting entities with setting up QMS processes, audits & certifications) & re-active support related to production quality issue resolution, PHO and FCA support)
• Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program.
• Responsible for communicating business-related issues or opportunities to next management level
• Lead, coordination and/or preparation of internal and external audits in accordance with regulatory standards (including FDA and its equivalents outside the US as well as other government regulatory agencies / authorities) for the Operating Unit
• Perform trend analyses and report compliance observations to identify areas in need of improvement
• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Mastering knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/ Regulation, HIPPA (Healthcare Information Patient Privacy Act) and ISO (International Organization for Standardization) requirements through the updating of policies and procedures and acting as a liaison with appropriate policy experts.
• Excellent writing and editing skills, and computer skills.
• Travel within US and International approximately 25%.

• Bachelor’s Degree
• YEARS OF
  
  EXPERIENCE:
• Minimum of 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience
• Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR and ISO 13485, and MDS