07 Aug Medtronic r27800 Regulatory Affairs Specialist – Cardiac Surgery
Medtronic r27800 Regulatory Affairs Specialist – Cardiac Surgery is a highly specialized role focused on ensuring regulatory compliance for life-saving surgical devices. At the intersection of healthcare innovation and global regulations, this position plays a key part in the development, approval, and oversight of cardiac surgical technologies. Professionals in this role navigate complex standards such as FDA and EU MDR while collaborating with cross-functional teams to bring safe, effective devices to market. This article explores the responsibilities, qualifications, and career potential of the R27800 position and compares it with similar roles at leading competitors in the medical device industry.
What Does the R27800 Job Code at Medtronic Represent?
The job code R27800 is an internal reference used by Medtronic to identify a specific opening within their Cardiac Surgery Regulatory Affairs team. While the code itself might not be publicly detailed, it typically corresponds to a mid to senior-level regulatory specialist position. These roles are generally hybrid, located in Medtronic’s main offices like Mounds View, Minnesota, with responsibilities tied to cardiac surgery device portfolios.
Such coding allows HR and hiring teams to track, manage, and organize applications across departments efficiently. For job seekers, recognizing and referring to the job code helps during application tracking and communication with recruiters. The R27800 position includes responsibilities such as coordinating with design teams, preparing regulatory submissions, and working on global product registrations. Understanding the role behind the code gives candidates a clear insight into the expectations and the professional level required for this highly specialized position in the medical device industry.
Overview of the Regulatory Affairs Specialist Role in Cardiac Surgery
The Regulatory Affairs Specialist – Cardiac Surgery at Medtronic serves as the link between innovative surgical device development and regulatory approval bodies. This specialist ensures all cardiac products comply with global health authority standards throughout the product lifecycle. From premarket strategies to post-market compliance, this role is vital to ensuring patient safety and maintaining market access.
In the cardiac surgery division, the role requires in-depth knowledge of regulatory pathways such as FDA 510(k), PMA submissions, and EU MDR technical files. Specialists are expected to provide guidance to cross-functional teams including engineering, quality assurance, and clinical affairs. They collaborate to create documentation, manage timelines, and respond to health authority inquiries. This role is highly strategic and ensures that Medtronic’s devices remain available and compliant across various global markets, ultimately supporting surgeons and patients with effective, lifesaving technology.
Required Qualifications for R27800 Regulatory Affairs Position
The Medtronic R27800 role typically requires a Bachelor’s degree in engineering, life sciences, or a related technical field, with 2–5 years of experience in regulatory affairs or a similar compliance-related field. Candidates with Master’s degrees or RAC (Regulatory Affairs Certification) credentials are often given preference. Demonstrated knowledge of medical device regulations, especially in cardiovascular applications, is critical for this role.
Beyond academic qualifications, candidates are expected to understand key regulatory frameworks such as the FDA, ISO 13485, and EU MDR. Experience with global product submissions, technical documentation, and internal audit processes is essential. Medtronic also values professionals with strong communication and project management skills, as the role involves regular coordination with cross-functional teams and regulatory bodies. Individuals looking to apply for the R27800 position must show both technical depth and the ability to manage documentation processes accurately and efficiently in a fast-paced, innovation-driven environment.
Key Responsibilities and Daily Duties of the Role
A Regulatory Affairs Specialist in cardiac surgery at Medtronic manages product submissions and ensures ongoing compliance with regulatory requirements globally. Responsibilities include preparing FDA 510(k), PMA, CE mark, and other international submissions for cardiac surgery products. The specialist also reviews engineering changes, maintains design dossiers, and leads post-market surveillance activities including complaints and vigilance reporting.
Daily duties often include interacting with design engineers, attending cross-functional meetings, and providing regulatory guidance during new product development. Specialists track regulatory timelines, manage documentation systems, and support audits and inspections. They also respond to inquiries from regulatory authorities and support the creation of labeling, instructions for use, and marketing materials. The role is dynamic and demands a high level of organization, accuracy, and regulatory acumen, as the individual must balance innovation with compliance while ensuring timely product delivery to healthcare providers around the world.
Essential Regulatory Knowledge: FDA, EU MDR, and ISO Standards
The Medtronic R27800 role requires expertise in regulatory frameworks that govern cardiac surgical devices. This includes the FDA’s 21 CFR Part 820, which regulates quality systems for medical devices in the U.S., and the EU MDR, which outlines requirements for CE marking and post-market surveillance in Europe. Familiarity with Health Canada, TGA (Australia), and other international regulatory bodies is also highly beneficial.
In addition to country-specific regulations, knowledge of ISO standards such as ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management) is essential. Specialists must ensure that all product development, testing, and documentation align with these standards. The role also involves supporting clinical evaluations, design controls, and hazard analysis. A regulatory affairs professional in cardiac surgery must navigate these standards confidently to lead successful submissions, avoid delays, and maintain patient safety, especially when working on life-critical technologies like heart valves and bypass equipment.
Soft Skills and Interdepartmental Collaboration Expectations
While technical expertise is critical, soft skills are equally essential for success in the R27800 regulatory affairs role. Professionals in this position must demonstrate excellent written and verbal communication skills, as they routinely coordinate with R&D, clinical, quality, and marketing teams. Clarity and precision in communication are vital when crafting regulatory submissions or responding to government inquiries.
Interdepartmental collaboration is a daily part of the role. Specialists are expected to align project timelines with product development and marketing goals, all while maintaining regulatory integrity. Problem-solving skills, adaptability, and conflict resolution are valuable assets. The ability to lead meetings, influence stakeholders, and present data persuasively strengthens the individual’s role within multidisciplinary teams. These soft skills ensure regulatory processes move forward without delays, enabling Medtronic to bring cutting-edge cardiac technologies to market efficiently and responsibly.
Medtronic r27800 Regulatory Affairs Specialist – Cardiac Surgery: Strategic Overview
Medtronic’s cardiac surgery division focuses on delivering innovative technologies that support open-heart and minimally invasive surgical procedures. This includes devices such as heart valves, perfusion systems, aortic tissue repair tools, and related surgical instruments. The Regulatory Affairs Specialist R27800 plays a strategic role in ensuring these products meet approval and compliance standards across global markets.
This division aligns with Medtronic’s overall mission to improve patient outcomes and extend lives. Regulatory professionals support this mission by ensuring that every product is legally approved, technically validated, and properly labeled. They collaborate with engineering, clinical, and legal teams to support submissions and audits. The cardiac surgery division is one of Medtronic’s most regulated and life-critical sectors, which makes regulatory expertise vital. A specialist in this team not only safeguards compliance but contributes directly to the safe and timely release of devices that save lives in surgical theaters worldwide.
Comparison with Similar Roles at Boston Scientific and Abbott
Medtronic’s R27800 position is similar in function to regulatory roles at Boston Scientific and Abbott, two of its major competitors in the cardiac surgery space. All three companies require knowledge of FDA and EU MDR processes, technical file compilation, and coordination across development teams. However, Medtronic often focuses more on Class III surgical devices, which tend to have stricter submission requirements.
At Boston Scientific, regulatory specialists may work more frequently on catheter-based interventional devices, while Abbott focuses on both electrophysiology and structural heart products. Career levels, job descriptions, and salary bands are comparable across these firms, but Medtronic’s global footprint and hybrid working model give it a competitive edge. Moreover, Medtronic emphasizes leadership development and cross-border regulatory experience, which can be beneficial for professionals looking to expand their careers internationally in the long term.
Career Growth Path: From Specialist to Principal in Regulatory Affairs
Medtronic offers a clear career development pathway for professionals in regulatory affairs. Starting from the Associate level, employees can progress to Specialist, Senior Specialist, Principal, and eventually into management roles such as Regulatory Affairs Manager or Director. Each level brings more complex projects, increased leadership responsibilities, and broader global exposure.
The R27800 Specialist position is often a mid-tier role with a focus on independent project management, cross-functional collaboration, and submission ownership. Advancement depends on both technical performance and leadership abilities. Medtronic supports career development through mentoring, certification sponsorship (e.g., RAC), and internal promotion opportunities. Employees are also encouraged to explore other divisions such as neuromodulation, spine, or diabetes, enhancing their skill sets and mobility within the company. This structured growth system ensures that regulatory professionals can build long-term, impactful careers while contributing to critical healthcare innovations.
Compensation and Benefits Offered for R27800 Position
The salary for a Regulatory Affairs Specialist – Cardiac Surgery at Medtronic typically ranges from $92,000 to $138,000 annually, depending on experience and geographic location. In addition to competitive pay, Medtronic offers a comprehensive benefits package, which includes medical, dental, and vision insurance, along with a generous 401(k) retirement plan and company match.
Employees also receive benefits such as tuition reimbursement, performance bonuses, stock purchase plans, and paid time off. Medtronic emphasizes employee wellness and work-life balance, offering hybrid or remote work flexibility when possible. The company is also known for its professional development support, providing access to internal training platforms, leadership courses, and networking programs. These compensation and benefit structures are designed to attract top regulatory talent and reward them for their technical contributions and compliance leadership in highly regulated sectors like cardiac surgery.
Job Location and Hybrid Work Flexibility at Medtronic
The Medtronic R27800 position is primarily based in Mounds View, Minnesota—a major Medtronic facility for cardiac and vascular operations. However, the role is often listed as hybrid, which allows employees to work from home several days a week while still attending critical in-person meetings, audits, or lab inspections as needed.
This flexibility is a major draw for candidates who seek work-life balance without compromising on career opportunities. Hybrid work arrangements also support productivity by allowing specialists to focus on documentation and submission tasks in a distraction-free environment. Medtronic ensures that remote collaboration tools, digital platforms, and project management systems are fully integrated to support seamless hybrid workflows. As regulatory teams are increasingly global, hybrid flexibility helps connect with colleagues and health authorities across multiple time zones while maintaining compliance and quality standards.
Application Process and Interview Tips for Medtronic R27800
Applying for the R27800 role at Medtronic begins with submitting an online application through the company’s career portal. Candidates should ensure their resume is tailored to include keywords related to cardiac surgery regulatory experience, such as FDA 510(k), EU MDR, technical file, post-market compliance, and Class III medical devices. Including metrics or examples of past regulatory submissions can also strengthen your application.
If shortlisted, candidates typically undergo an initial HR screening followed by technical interviews with hiring managers and cross-functional partners. You may be asked scenario-based questions related to risk assessment, regulatory strategy, and product lifecycle management. It’s important to prepare examples that demonstrate your ability to manage regulatory documentation, communicate with engineering teams, and respond to audit findings. Familiarity with Medtronic’s mission and values can also enhance your cultural fit during interviews.
Why Choose Medtronic Over Competitors for Regulatory Careers?
Medtronic offers several advantages over its competitors for regulatory professionals. First, its extensive portfolio across various therapeutic areas allows employees to gain diverse experience within a single organization. The company emphasizes cross-functional collaboration, global exposure, and regulatory leadership training, which supports long-term career advancement.
In addition, Medtronic’s mission-driven culture sets it apart. Employees are encouraged to focus not just on compliance, but also on improving global health outcomes. The company’s investments in hybrid work, diversity and inclusion, and professional development make it an attractive workplace for top-tier talent. Compared to competitors, Medtronic also provides broader career mobility across international markets and other regulatory domains. This makes the R27800 role not just a job, but a gateway to a fulfilling, impactful regulatory affairs career in the cardiac surgery space.
Future of Regulatory Affairs in Cardiac Surgery: Trends and Innovation
The field of regulatory affairs in cardiac surgery is evolving rapidly due to technological innovation, stricter global regulations, and increasing demand for minimally invasive procedures. Regulatory specialists must now stay ahead of emerging trends like AI-assisted surgical devices, smart implants, and digital health integration, all of which present new compliance challenges.
As Medtronic and its competitors push forward with advanced cardiac technologies, regulatory professionals are becoming strategic partners in innovation. They help design clinical trial strategies, advise on global regulatory pathways, and ensure devices meet safety and effectiveness standards before reaching patients. In the future, professionals in roles like R27800 will need to develop cross-disciplinary skills that blend engineering, policy, and data science to navigate a fast-changing global landscape. Continuous learning and adaptability will be key to remaining relevant and impactful in the regulatory affairs domain.
FAQ’s
What is the Medtronic R27800 job role about?
The Medtronic R27800 Regulatory Affairs Specialist – Cardiac Surgery is a role responsible for ensuring that Medtronic’s cardiac surgery devices meet global regulatory standards, including FDA and EU MDR compliance.
What qualifications are required for the R27800 position?
Applicants typically need a bachelor’s degree in science or engineering and 2–5 years of regulatory experience in medical devices, preferably involving cardiac or Class III devices.
Where is the R27800 role located?
The position is usually based in Mounds View, Minnesota, with hybrid work flexibility allowing a mix of onsite and remote work.
How does this role compare with competitors like Abbott?
Compared to similar roles at Abbott or Boston Scientific, Medtronic offers broader exposure to surgical device portfolios, international regulatory pathways, and career mobility.
What salary range can I expect in this position?
The R27800 Regulatory Affairs Specialist role at Medtronic typically pays between $92,000 and $138,000 per year, depending on experience and qualifications.
Conclusion:
The Medtronic R27800 Regulatory Affairs Specialist – Cardiac Surgery position is a high-impact opportunity for professionals seeking to influence the future of cardiac care. This role bridges regulatory expertise with innovation, ensuring compliance while supporting the development of life-saving surgical technologies. With strong career pathways, competitive compensation, and hybrid flexibility, Medtronic stands out as an employer of choice in the medical device industry. As the demand for regulatory professionals grows globally, R27800 offers a strategic role at the intersection of healthcare advancement and global compliance. For those ready to lead with purpose, this role is a powerful next step.
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