7 Medtronic jobs in Rogers

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

We are looking for our next Senior Regulatory Quality Specialist to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Regulatory Quality Senior Specialist position would be structured under the Global Regulatory Services (GRS) function managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a RA QA Specialist is to combine the knowledge of Regulatory, Quality and Compliance to lead and assist implementation projects for emerging regulations and supporting quality compliance related activities for the GRS department. With limited supervision, coordinates and compiles regulatory procedures/processes and leads Regulatory systems projects to assure business needs are met and optimized for efficiency and effectiveness. Communicate with business partners to author and implement regulatory procedural changes. Support ongoing RA Operation system implementations and process improvements.

What You'll Work On

• Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams
• Develop new regulatory policies, processes and SOPs
• Facilitate procedure implementation
• Provide strategic input and technical guidance on regulatory requirements for process decisions
• Evaluate regulatory risks of division policies, processes, procedures
• Drive change order activities
• Create supplemental training materials
• Review and follow document quality system structure
• Lead team meetings and document meeting minutes
• Analyzes quality reports and metrics from tracking tools; identifies trends and ramifications
• Work on process workflow development teams collaborating with Abbott IT system enhancement teams

Required Qualifications

• Bachelor's degree or an equivalent combination of education and work experience
• Minimum 3 years' experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Experience with submission/registration types and requirements.
• Write and edit technical documents.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

• Master's Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.
• 5+ years' experience in a regulated industry
• Knowledge of Regulations
• Familiarity with Regulatory Affairs departmental responsibilities and processes
• CAPA experience
• Windchill experience
• Procedural Writing
• Regulatory Change Assessment
• International Product Registration support
• Ad and Promotional Material - Regulatory Review
• EU and US medical device compliance
• Project management skills organize and host meetings
• Quality System maintenance activities
• Documenting justification for change from Regulatory perspective
• Regulatory history, guidelines, policies, standards, practices, requirements and precedents
• GDP
• Experience working in the Medical Device industry.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

The base pay for this position is $75,300.00 $150,700.00 In specific locations, the pay range may vary from the range posted.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol:

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Reporting to the SVP of Clinical and Regulatory, the Director of Regulatory Affairs will support the strategic direction and lead the day-to-day execution of global regulatory activities. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and ensuring compliance with global requirements related to market authorizations, post-market surveillance, and regulatory reporting.

At Anteris, you’ll be part of a high-caliber team advancing a transformative therapy for aortic stenosis. We value accountability, objectivity, respect, teamwork, integrity, and courage, and we’re united by a shared purpose: improving patient lives through disruptive innovation. We’re building something remarkable—and we’re just getting started.

Key Responsibilities

• Create and execute global regulatory strategy for all Anteris products in alignment with business goals.
• Serve as a strategic advisor to the executive team on the regulatory implications of product and process changes.
• Develop and lead a high-performing global Regulatory Affairs team that supports company objectives across product lifecycles.
• Oversee department budget planning and resource allocation to ensure alignment with regulatory and business priorities.
• Ensure Regulatory Affairs participation on cross-functional project teams supporting new product development and product modifications.
• Lead timely renewals of global licenses, certificates, and product registrations.
• Provide guidance on the application of external standards across all projects.
• Maintain complete, audit-ready regulatory documentation and manage global submission packages.
• Direct regulatory activities related to field corrective actions and ensure appropriate product re-submissions and ongoing approvals.
• Support Quality Assurance in maintaining ISO/CE Mark certifications and related regulatory audits.
• Monitor evolving global regulatory requirements and assess their impact on Anteris products and systems.
• Conduct regulatory assessments for reportability and submit FDA MDRs and international vigilance reports as needed for tissue-based products.
• Review Engineering Change Requests (ECRs) for global regulatory impact.
• Lead or participate in regulatory review of promotional materials.
• Author, review, and approve internal procedures related to regulatory affairs operations and compliance.

Skills, Knowledge, Experience & Qualifications

• Bachelor’s degree in a technical field required; advanced degree preferred.
• 10–12 years of experience in the medical device industry, ideally with exposure to structural heart technologies.
• At least 5 years of experience leading a Regulatory Affairs team.
• Hands-on leadership of regulatory submissions for Class III/PMA devices, including FDA (IDE, PMA) and EU (MDR, CA, CE Mark) pathways.
• Experience working with Notified Bodies through CE submissions and post-market requirements.
• Strong knowledge of global regulatory standards and quality systems, including ISO 13485, GMP, GCP, GLP, QSR, and MDR.
• Exceptional communication skills with the ability to craft clear, concise regulatory documents and collaborate across functions and levels.
• Proven project management skills, with a track record of driving robust submissions and compliance initiatives.
• Innovative, solution-oriented mindset with a strong focus on regulatory rigor and business alignment.
• Demonstrated leadership that fosters cross-functional collaboration, champions innovation, and drives accountability.
• A disciplined, strategic approach to risk management and regulatory compliance.
• RAC certification preferred.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & PTO
• Employee Assistance Program
• Inclusive Team Environment

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. Wehave a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization.Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.