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

Job description

We anticipate the application window for this opening will close on - 31 Aug 2026 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. A Day in the LifeAcross 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. Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions Check us out on LinkedIn: Medtronic Pelvic Health A Day in the Life As a Principal Clinical Evaluation Medical Writer, you will translate complex clinical and scientific evidence into clear, defensible clinical evaluation deliverables that support regulatory compliance, submissions, and business decisions across Neuromodulation and Pelvic Health therapies. Partnering with cross-functional teams, you will assess evidence from literature, clinical studies, real-world data, post-market surveillance, risk management, and testing activities to evaluate device safety, performance, and clinical benefit. You may also contribute to broader regulatory and medical writing initiatives, including evidence summaries, benefit-risk assessments, regulatory responses, and clinical strategy activities that support regulatory success and improved patient outcomes. This role offers the opportunity to shape how clinical evidence is evaluated and communicated for therapies that improve patients' lives. In addition to developing deep expertise in clinical evaluation, you will gain exposure to a broad range of scientific, regulatory, and evidence-based writing activities, providing meaningful opportunities to expand your impact across the product lifecycle. Responsibilities include, but are not limited to: 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 the 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. 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. Location: Rice Creek/Fridley, MN (Onsite) Minimum Requirement (Basic Qualifications): To be considered for this position, the following Basic Qualifications must be evident on your resume Requires a Baccalaureate degree in life sciences, healthcare, engineering or related field and a minimum 7 years of relevant experience, or advanced degree life sciences, healthcare, engineering or related field and a minimum of 5 years of relevant experience. Nice To Have (Preferred Qualifications): Advanced degree in a life sciences, healthcare, engineering, or related discipline (M.S., MPH, PharmD, PhD, MD, or equivalent) is preferred. 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. 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to