Principal Clinical Evaluation Medical Writer - NMPH - Fridley, MN (Onsite)

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.

About the role

Across our global Neuroscience organization, we develop innovative therapies for complex neurological, spinal, and pelvic health conditions. Our Neuromodulation team delivers advanced solutions for chronic pain and movement disorders through spinal cord stimulation, deep brain stimulation, and targeted drug delivery systems. Our Pelvic Health team advances minimally invasive neuromodulation therapies for bladder and bowel control conditions, helping patients regain function and improve quality of life.

Located at Medtronic's location in Rice Creek/Fridley, MN, this role is onsite four days per week and requires <10% travel.

Responsibilities

• Review, evaluate, and summarize scientific literature relevant to the product portfolio.
• Identify and report complaints, adverse events, and other reportable findings from published literature to Global Clinical and Regulatory stakeholders.
• Develop responses to regulatory authority, audit, and submission-related inquiries.
• Maintain and manage a database of peer-reviewed literature and clinical evidence.
• Critically appraise, analyze, synthesize, and interpret clinical evidence from all available sources.
• Conduct comprehensive literature searches and perform a critical evaluation of clinical data and evidence.
• Develop and maintain state-of-the-art assessments for product families in support of their intended use and regulatory requirements.
• Create, update, and maintain clinical evaluation plans, reports, and support documents for regulatory authorities.
• Review and approve technical, clinical, and regulatory documentation supporting device development and lifecycle management.
• Collaborate with cross-functional teams to ensure clinical evidence strategies align with regulatory, quality, and business objectives.

Requirements

Successful candidates bring:

• Strong scientific judgment and evidence synthesis expertise, with the ability to evaluate and integrate evidence from scientific literature, clinical studies, real-world data, post-market surveillance, and other sources into balanced, evidence-based conclusions regarding device safety, performance, and clinical benefit.
• Relevant experience in medical devices, life sciences, clinical research, regulatory affairs, clinical evaluation, or scientific/medical writing, with a solid understanding of evidence appraisal, clinical research principles, and regulated product development.
• A regulatory and benefit-risk mindset, including experience applying scientific evidence to support regulatory submissions, safety and performance assessments, risk management activities, or evidence-based decision-making in a regulated environment.
• Learning agility, adaptability, and senior-level independence, with the ability to quickly develop expertise in new areas, navigate ambiguity, manage evolving priorities, proactively identify risks and gaps, and operate effectively with limited oversight.
• Excellent communication, collaboration, and influence skills, with the ability to translate complex scientific information into clear, meaningful insights and drive alignment across cross-functional teams.
• Leadership and mentoring capabilities, serving as a trusted scientific resource who leads complex initiatives that advance clinical evidence and evaluation practices.

Qualifications

Minimum Requirements:

• Baccalaureate degree in life sciences, healthcare, engineering, or related field and a minimum of 7 years of relevant experience, or advanced degree in life sciences, healthcare, engineering, or related field and a minimum of 5 years of relevant experience.
• 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.

Preferred Qualifications:

• Advanced degree in a life sciences, healthcare, engineering, or related discipline (M.S., MPH, PharmD, PhD, MD, or equivalent).
• Experience authoring or contributing to clinical, regulatory, or scientific deliverables within the medical device or highly regulated life sciences industry.
• Demonstrated ability to critically evaluate and synthesize complex evidence from scientific literature, clinical studies, real-world data, post-market surveillance, and other relevant sources to support evidence-based conclusions.
• Strong understanding of clinical research methods, evidence appraisal, epidemiology, biostatistics, and/or clinical evaluation principles, with the ability to apply these concepts to support balanced, evidence-based conclusions.
• Knowledge of global medical device regulations and standards, including EU MDR, MEDDEV 2.7.1 Rev. 4, ISO 14155, ISO 14971, and related guidance.
• Experience supporting regulatory agency, notified body, or audit interactions.
• Strong analytical, communication, project management, and stakeholder management skills, with the ability to influence across cross-functional teams.
• Demonstrated success working independently in complex, fast-paced, highly regulated environments, with the learning agility, judgment, adaptability, and seniority to manage ambiguity, balance multiple priorities, quickly build expertise in new requirements or therapy areas, and guide evidence-based decision-making across cross-functional teams.

Benefits

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions and offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

• 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, including the Medtronic Incentive Plan (MIP)
• 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)

Pay

Salary ranges for U.S. (excluding Puerto Rico) locations: $131,200.00 - $196,800.00. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Schedule

This role is onsite four days per week and requires <10% travel.