Sr Compliance Specialist

Medtronic•Minneapolis, MN

1d•$89,600 - $134,400•Hybrid

About The Position

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.

Requirements

Bachelor’s Degree
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 MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry. Special focus on Core QMS, Design Control & Manufacturing processes/requirements.
Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the "big picture". Desire to follow an audit trail to identify risks, non-conformances, true root cause, etc.
Outstanding written, oral communication, and presentation skills
Sound judgement, ability to make decisions, work independently, and demonstrated leadership skills
Ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and escalate issues.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

3 or more years relevant experience in a Design & Development and/or Manufacturing setting
Experience supporting and or participating in regulatory inspections and audits.

Responsibilities

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%.

Benefits

Competitive Salary
Flexible Benefits Package
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)