Chief Regulatory Officer – Neuro Implant Compliance | Minneapolis, MN

Are you a regulatory leader with deep expertise in navigating complex compliance frameworks in the medical device and neurotechnology sectors? We are seeking a strategic and experienced Chief Regulatory Officer (CRO) to oversee regulatory compliance and quality assurance for a pioneering neuro implant company in Minneapolis, MN. This is a unique opportunity to play a mission-critical role in ensuring patient safety and guiding cutting-edge innovations through global regulatory pathways. If you’re passionate about neurotech and thrive in a fast-paced, high-impact environment, this role is for you.

Lead Regulatory Strategy for Next-Gen Neurotechnology

A breakthrough neuro implant company based in Minneapolis, MN is searching for a Chief Regulatory Officer to lead its global regulatory and quality systems. The ideal candidate will have extensive experience with FDA, EMA, and international device approval processes, along with a strong understanding of clinical trials, post-market surveillance, and risk management. This is your chance to help shape the future of neuroscience by ensuring that life-changing technologies meet the highest safety and compliance standards.

Key Responsibilities of the Chief Regulatory Officer – Neuro Implant Compliance

Regulatory Strategy & Execution: Develop and implement comprehensive regulatory strategies to support global approvals for neuro implant technologies. Ensure alignment with business objectives and evolving international regulatory landscapes, including FDA (510(k), PMA), EMA, and other health authorities.

Compliance & Quality Assurance Leadership: Lead the design, implementation, and continuous improvement of quality management systems (QMS) in accordance with ISO 13485, FDA QSR, and other applicable standards. Promote a culture of quality and compliance across the organization.

Product Lifecycle Oversight: Guide regulatory planning from early R&D through clinical trials, market authorization, and post-market activities. Ensure compliant design controls, risk assessments, labeling, and documentation throughout the product lifecycle.

Cross-Functional Collaboration: Collaborate with R&D, clinical, legal, manufacturing, and marketing teams to ensure regulatory considerations are integrated into product development and commercialization strategies. Act as a regulatory subject matter expert across departments.

Clinical & Preclinical Support: Provide regulatory input on clinical trial design, study protocols, and ethical considerations. Lead regulatory submissions including IDEs, clinical trial applications, and amendments to ensure timely study initiation and execution.

Global Market Access: Oversee and manage the preparation and submission of regulatory filings to support entry into U.S., EU, and international markets. Monitor and adapt to changing global regulations to maintain product access and compliance.

Risk Management & Surveillance: Lead risk evaluation and mitigation activities including post-market surveillance, vigilance reporting, and field corrective actions. Ensure compliance with regulatory reporting requirements and ongoing product safety monitoring.

Regulatory Intelligence & Policy Engagement: Stay abreast of emerging regulatory trends and actively engage with regulatory bodies, industry groups, and standards organizations. Influence and anticipate regulatory shifts to position the company as a leader in compliance excellence.

Team Leadership & Development: Build and lead a high-performing regulatory and quality team. Mentor staff, promote continuous learning, and ensure operational readiness for audits and inspections.

Inspection Readiness & Audit Management: Lead preparation for regulatory audits and inspections. Serve as the primary contact for regulatory agencies and ensure effective resolution of findings or observations.

What the Client is Looking for in You

As the Chief Regulatory Officer (CRO) – Neuro Implant Compliance, the client is seeking a regulatory visionary with a deep understanding of global medical device regulations, particularly in the neurotechnology and implantable device space. You should be a mission-driven leader who brings strategic foresight, technical expertise, and a relentless focus on quality, patient safety, and innovation.

Proven Expertise in Medical Device Regulatory Affairs

The ideal candidate will have extensive experience in navigating U.S. FDA (510(k), PMA), EU MDR, and other international medical device regulatory frameworks. You should have successfully led regulatory strategy and submissions for Class III or implantable neurotechnology devices, ensuring full compliance across all phases of product development and commercialization.

Strategic Regulatory Leadership with a Global Perspective

The client values a CRO who can align regulatory pathways with business objectives. You must possess the ability to anticipate regulatory changes, assess market readiness, and implement scalable compliance strategies that accelerate product approval and maintain global market access. Experience managing regulatory affairs in a global, multi-product portfolio environment is highly desirable.

Strong Background in Quality and Compliance Systems

A thorough understanding of quality systems and standards such as ISO 13485, FDA QSR, and risk management under ISO 14971 is essential. The client seeks a leader who can maintain and evolve a robust Quality Management System, manage audits with confidence, and lead root cause analysis and corrective actions with discipline and transparency.

Exceptional Communicator and Cross-Functional Collaborator

You must be comfortable acting as the regulatory face of the organization—both internally and externally. The ideal candidate can translate complex regulatory requirements into clear, actionable guidance for technical, clinical, and executive teams. Experience working with legal counsel, clinical affairs, R&D, and marketing to ensure alignment across all stakeholders is crucial.

Demonstrated Experience with Clinical and Post-Market Activities

The client is looking for someone who understands the full product lifecycle—from clinical trial design and regulatory submissions to post-market surveillance, vigilance, and labeling compliance. A CRO who can support IDEs, PMAs, and clinical evaluation reports while ensuring timely reporting and risk mitigation will be highly valued.

Leadership in a High-Stakes, Innovation-Driven Environment

You should bring a calm, decisive leadership style to high-pressure situations. The client is looking for someone who can manage complex regulatory challenges with integrity, build high-performing regulatory and quality teams, and foster a culture of accountability and continuous improvement.

Commitment to Ethical Standards and Patient Safety

Above all, the client seeks a CRO who leads with ethics and puts patient safety first. You must demonstrate a commitment to upholding the highest standards of integrity, transparency, and compliance in all regulatory matters.

FAQs About the Role – Chief Regulatory Officer – Neuro Implant Compliance

What are the key responsibilities of the Chief Regulatory Officer in this role?

As the Chief Regulatory Officer (CRO), you will be responsible for leading the global regulatory and quality strategy for advanced neuro implant technologies. Key responsibilities include overseeing regulatory submissions (e.g., FDA, EMA), ensuring compliance with ISO and FDA QSR standards, managing audits, driving post-market surveillance, and collaborating cross-functionally with clinical, R&D, and executive teams. You will also play a pivotal role in shaping regulatory intelligence and influencing internal processes to align with evolving global requirements.

What qualifications and experience are required for this position?

The ideal candidate will have extensive regulatory affairs leadership experience within the medical device or neurotechnology sectors, especially in Class III or implantable devices. A deep understanding of FDA 510(k)/PMA, EU MDR, and ISO 13485 compliance is essential. Experience in managing global regulatory submissions, leading audits, and implementing quality systems is required. A scientific, engineering, or regulatory degree is preferred; advanced degrees or RAC certification are considered a plus.

What leadership qualities are essential for this role?

The client seeks a strategic, mission-driven leader with exceptional communication, analytical, and decision-making skills. You should be collaborative, detail-oriented, and capable of managing high-stakes compliance matters. The ability to lead cross-functional teams, influence regulatory strategy at the executive level, and inspire a culture of quality and accountability is essential.

What challenges can I expect in this role?

This role involves navigating complex and evolving regulatory frameworks across global markets. You will face challenges such as responding to regulatory changes, managing clinical and post-market compliance risks, and ensuring timely approvals for innovative neuro implant technologies. The position demands precision, adaptability, and the ability to lead under pressure in a rapidly evolving industry.

What is the expected impact of the CRO on the company’s success?

The Chief Regulatory Officer will have a direct and substantial impact on the company’s ability to bring breakthrough neurotechnologies to market safely and efficiently. Your leadership will ensure that products meet the highest regulatory standards, thereby enabling innovation, supporting commercial success, and upholding patient safety and trust.

What is the company’s culture and work environment like?

The company fosters a purpose-driven, innovative, and highly collaborative environment focused on transforming lives through neuroscience. They value integrity, scientific rigor, and a patient-first mindset. As a senior leader, you will contribute to shaping a culture that embraces regulatory excellence, continuous learning, and cross-functional teamwork.

What Remuneration Can You Expect from This Job?

As the Chief Regulatory Officer (CRO) – Neuro Implant Compliance based in Minneapolis, MN, you can expect a comprehensive and competitive executive compensation package designed to attract and retain top regulatory leadership talent in the cutting-edge neurotechnology sector. The remuneration for this role typically includes:

Base Salary

The base salary for a Chief Regulatory Officer in the medical device and neuro implant industry generally ranges from $220,000 to $400,000 annually, depending on the size of the company, product portfolio complexity, and market presence. Larger or publicly traded companies may offer higher base salaries reflecting the strategic importance of the role.

Performance-Based Bonuses

In addition to the base salary, performance-based bonuses are a significant part of the compensation, often tied to regulatory milestones, successful product approvals, compliance audit outcomes, and overall company performance. Bonus potential typically ranges from 20% to 50% of the base salary.

Equity & Long-Term Incentives

Many neurotechnology companies offer equity-based incentives such as stock options, restricted stock units (RSUs), or performance shares. These equity awards align your interests with company growth and innovation success, often constituting a meaningful portion of the total compensation package.

Profit Sharing & Deferred Compensation

Some organizations provide profit-sharing plans or deferred compensation programs that reward sustained compliance excellence and business growth over multiple years, further enhancing long-term financial benefits.

Executive Benefits & Perks

The CRO role often includes a robust benefits package, including:

Comprehensive health, dental, and vision insurance
Retirement savings plans with company contributions (401(k), pension plans)
Executive wellness and professional development programs
Travel allowances or company-sponsored relocation support if applicable
Expense accounts for regulatory affairs activities and industry engagement

Signing Bonuses & Relocation Assistance

For highly qualified candidates, signing bonuses and relocation packages may be offered to facilitate a smooth transition. These incentives typically range from $20,000 to $100,000, depending on the candidate’s experience and relocation needs.

Total Compensation Outlook

When factoring in base salary, bonuses, equity, and benefits, total annual compensation for a Chief Regulatory Officer in the neuro implant space can range from $300,000 to $700,000 or more at leading companies. This package reflects the critical role the CRO plays in enabling regulatory compliance, product innovation, and global market access.

How to Apply

If you are a seasoned regulatory leader with deep expertise in neuro implant compliance and a passion for driving innovation in medical technology, we invite you to apply for the Chief Regulatory Officer – Neuro Implant Compliance role based in Minneapolis, MN. This is a unique opportunity to lead regulatory strategy at the forefront of groundbreaking neurotechnology and ensure patient safety while enabling global market access.

To apply, please submit your resume along with a cover letter detailing your experience in medical device regulatory affairs, specifically related to neuro implant or Class III devices. Highlight your success in leading global regulatory submissions, managing quality systems (ISO 13485, FDA QSR), and navigating complex regulatory landscapes. Emphasize your leadership skills in building high-performing teams and your ability to collaborate cross-functionally to achieve compliance excellence.

This role offers a high-impact leadership opportunity where you will shape regulatory pathways, influence product innovation, and uphold the highest standards of quality and safety. Apply today to advance your career as a Chief Regulatory Officer in a cutting-edge neurotechnology company based in Minneapolis!

For additional information or to explore similar regulatory leadership opportunities, please visit our Neuromodulation and Neuro Devices Executive Recruiters Page.

Job Category: Neuro Implant Compliance

Job Type: Full Time

Job Location: Minneapolis

Chief Regulatory Officer – Neuro Implant Compliance | Minneapolis, MN