Director of Regulatory Strategy – Jacksonville, FL | EU MDR Devices

We are seeking a highly experienced and visionary Director of Regulatory Strategy to lead our regulatory efforts for EU MDR devices. Based in Jacksonville, FL, this is an exceptional opportunity to take charge of the company’s regulatory strategy in a critical and evolving field. If you have a deep understanding of the EU Medical Device Regulation (MDR) and a track record of driving successful regulatory strategies, this is your chance to make a meaningful impact in the medical device industry.

Lead Regulatory Excellence for EU MDR Devices

As the Director of Regulatory Strategy, you will play a pivotal role in overseeing the regulatory strategies for EU MDR devices, ensuring compliance and aligning product development with the latest EU regulations. Your expertise in EU MDR will be essential in navigating the regulatory landscape and positioning the company for success in global markets. This is an exciting opportunity to shape the company’s regulatory vision and ensure successful market entry and sustainability for medical devices in the EU.

Key Responsibilities of the Director of Regulatory Strategy – EU MDR Devices

Regulatory Strategy Development: Lead the creation and implementation of comprehensive regulatory strategies to ensure compliance with EU MDR for medical devices. Guide the company’s approach to market entry, product lifecycle management, and regulatory approvals, aligning strategies with both internal objectives and external regulatory requirements.

EU MDR Compliance: Oversee and ensure the company’s adherence to all aspects of EU MDR, including product classification, conformity assessment procedures, and post-market surveillance. Ensure all products meet the necessary standards for CE marking and compliance with relevant European regulations.

Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Marketing, and Operations teams to ensure that regulatory considerations are integrated into product development and lifecycle processes. Drive collaboration between departments to address regulatory concerns and streamline processes for faster market approval.

Risk Management: Identify and assess regulatory risks related to product development, approval, and market introduction. Implement proactive risk mitigation strategies to minimize compliance issues and ensure timely market access for products.

Regulatory Submissions and Approvals: Manage and lead regulatory submission efforts, including Technical Files, Design Dossiers, and other necessary documentation for CE marking and EU MDR compliance. Ensure timely and accurate submissions to regulatory authorities, and manage the process of obtaining necessary approvals.

Market Surveillance & Post-Market Activities: Oversee post-market surveillance programs to monitor device performance, gather feedback, and address any issues related to product safety or efficacy. Ensure the company maintains compliance with ongoing EU MDR reporting and vigilance requirements.

Stakeholder Communication: Serve as the primary point of contact for regulatory bodies, external consultants, and industry associations. Maintain relationships with regulatory agencies, ensuring clear and effective communication of regulatory strategies, challenges, and progress.

Continuous Improvement & Innovation: Stay current on changes in EU MDR regulations and global regulatory trends. Ensure the company adapts to regulatory changes, enhancing processes and driving innovation in regulatory strategies to maintain competitive advantage.

Team Leadership & Development: Lead and mentor a regulatory affairs team, providing guidance and support to ensure they are aligned with strategic objectives and have the necessary resources to execute regulatory initiatives effectively.

Global Regulatory Strategy Integration: Collaborate with global teams to ensure alignment of EU MDR strategies with broader international regulatory requirements. Help navigate and drive compliance strategies for markets outside the EU as needed.

What the Client is Looking for in You

As the Director of Regulatory Strategy – EU MDR Devices, the client is seeking an experienced and strategic leader who has a deep understanding of the EU MDR landscape and the regulatory challenges faced by medical device companies. You should be an expert in regulatory affairs, with a proven ability to lead successful regulatory submissions, maintain compliance, and drive business success in a complex global market.

Expertise in EU MDR Compliance and Regulatory Affairs

The client is looking for a seasoned professional with extensive experience in managing regulatory strategies for medical devices under the EU MDR framework. You should have a solid understanding of all aspects of EU MDR, including product classification, technical documentation, post-market surveillance, and CE marking. Experience in preparing regulatory submissions and navigating complex regulatory environments is essential.

Strategic Mindset with a Focus on Market Access

As the Director of Regulatory Strategy, you must be able to develop and execute strategies that ensure timely and successful market access for medical devices in the EU. The ideal candidate will be capable of evaluating regulatory risks and opportunities, guiding teams to make data-driven decisions, and maintaining compliance throughout the product lifecycle. A forward-thinking approach to market expansion and regulatory landscape adaptation is highly valued.

Strong Leadership and Team Collaboration Skills

The client seeks a leader who can build and mentor a high-performing regulatory affairs team. You should be able to effectively communicate with cross-functional teams, including R&D, quality assurance, and operations, to ensure alignment with regulatory requirements. Experience in leading teams, driving regulatory initiatives, and fostering a culture of collaboration and innovation is crucial for success in this role.

Ability to Navigate Complex Regulatory Challenges

The role requires a strategic thinker who can proactively identify regulatory challenges and develop solutions to ensure compliance with EU MDR requirements. You should be comfortable managing the complexities of the regulatory process and adept at working with external agencies, consultants, and stakeholders to ensure smooth product approvals and market introduction.

In-Depth Knowledge of Risk Management and Regulatory Trends

The client values a candidate who can anticipate regulatory risks and navigate industry trends to maintain compliance and competitiveness. A strong understanding of risk management processes, post-market surveillance requirements, and vigilance reporting will be key to success in this role. The ideal candidate should be proactive in staying updated on evolving regulations and leveraging industry best practices.

Stakeholder Engagement and External Relationships

The ability to build strong relationships with regulatory bodies, industry associations, and external consultants is essential. The client seeks a Director who can effectively represent the company in regulatory discussions, manage external relationships, and ensure transparent communication with key stakeholders regarding regulatory strategies and challenges.

Commitment to Quality, Compliance, and Operational Excellence

Finally, the client values a leader who ensures that regulatory compliance is fully integrated into the company’s operations. You should be committed to maintaining high standards of quality and regulatory oversight while promoting operational efficiency and continuous improvement across regulatory processes.

FAQs About the Role – Director of Regulatory Strategy – EU MDR Devices

1. What are the key responsibilities of the Director of Regulatory Strategy in this role?

As the Director of Regulatory Strategy, you will be responsible for leading the development and execution of regulatory strategies to ensure compliance with EU MDR for medical devices. This includes overseeing regulatory submissions, managing post-market surveillance, mitigating regulatory risks, and ensuring market access for products. You will work closely with cross-functional teams to integrate regulatory considerations into product development and lifecycle management, while building and maintaining relationships with regulatory bodies and stakeholders.

2. What qualifications and experience are required for this position?

The ideal candidate should have extensive experience in regulatory affairs, specifically with EU MDR for medical devices. A deep understanding of the EU regulatory environment, including the preparation of technical documentation, CE marking, and post-market requirements, is essential. A degree in life sciences, engineering, or a related field is required, and advanced certifications or training in regulatory affairs (e.g., RAC) are highly desirable. Previous experience leading regulatory teams and managing successful regulatory submissions is crucial.

3. What leadership qualities are essential for this role?

The client is seeking a strategic leader with excellent communication and problem-solving skills. You should have the ability to lead cross-functional teams, manage complex regulatory challenges, and make data-driven decisions. Strong interpersonal skills are essential for building relationships with regulatory bodies, internal stakeholders, and external consultants. Additionally, the ability to think critically, anticipate regulatory changes, and adapt to evolving industry standards is vital.

4. What challenges can I expect in this role?

In this role, you will face challenges such as navigating complex and evolving EU MDR regulations, ensuring timely and successful regulatory approvals, and managing post-market surveillance. You will need to mitigate regulatory risks while ensuring compliance across multiple product lines. Balancing compliance with operational efficiency and product innovation in a fast-paced environment will also be key challenges. Additionally, staying updated on global regulatory trends and adapting strategies accordingly will require agility and foresight.

5. What is the expected impact of the Director of Regulatory Strategy on the company’s success?

The Director of Regulatory Strategy will play a critical role in ensuring the company’s products meet all EU MDR requirements, which directly impacts market access, product safety, and overall compliance. By leading successful regulatory submissions and maintaining adherence to evolving regulations, you will help the company bring innovative products to market on time, minimizing risks and optimizing revenue streams. Your strategic input will be essential in positioning the company as a leader in the medical device sector.

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

The company promotes a culture of innovation, collaboration, and regulatory excellence. You will work in a dynamic, fast-paced environment where your contributions are critical to the success of the company’s product portfolio. The company values leadership that fosters teamwork and accountability, as well as a commitment to quality and compliance. As the Director of Regulatory Strategy, you will have the opportunity to shape and enhance the company’s regulatory practices and culture while aligning them with business goals.

What Remuneration Can You Expect from This Job?

As the Director of Regulatory Strategy – EU MDR Devices in Jacksonville, FL, you can expect a highly competitive compensation package that is designed to attract top-tier professionals with expertise in regulatory affairs and the medical device industry. The remuneration for this role typically includes:

1. Base Salary
The base salary for the Director of Regulatory Strategy varies depending on the company’s size, industry standing, and the candidate’s experience. In the medical device industry, the annual base salary for this position typically ranges from $150,000 to $250,000, with larger organizations offering higher salaries based on experience and expertise.

2. Performance-Based Bonuses
In addition to the base salary, most compensation packages for senior regulatory positions include performance-based bonuses. These bonuses are typically tied to key business metrics such as successful regulatory approvals, market expansion, compliance milestones, and overall company performance. Performance bonuses can range from 20% to 50% of the base salary, depending on both individual and organizational performance.

3. Equity & Stock Options
Many companies offer equity-based incentives such as stock options, restricted stock units (RSUs), or performance shares as part of the compensation package. These incentives align your interests with the company’s long-term success and provide financial rewards as the company grows and performs well in the market. Equity grants can constitute a significant portion of the overall remuneration, especially in high-growth companies.

4. Long-Term Incentive Plans (LTIPs)
In addition to annual bonuses, companies may provide Long-Term Incentive Plans (LTIPs), which reward executives for sustained performance over several years. These programs encourage long-term growth and stability, offering additional financial incentives based on the company’s performance over extended periods.

5. Executive Benefits & Perks
As a senior executive, you will also be eligible for a comprehensive benefits package that includes:

Health, dental, and vision insurance
401(k) or pension plans with company contributions
Executive retirement plans
Company-provided vehicles or travel allowances
Executive wellness programs
Expense accounts for business development and networking

6. Signing Bonuses & Relocation Assistance
For highly sought-after candidates, companies may offer signing bonuses or relocation packages. These one-time incentives can range from $20,000 to $100,000, depending on the level of expertise required and the candidate’s qualifications.

Total Compensation Potential

When factoring in base salary, bonuses, equity incentives, and benefits, the total annual compensation for a Director of Regulatory Strategy can range from $200,000 to $400,000 or more, with high-growth or publicly traded companies offering even more lucrative packages. The total remuneration is designed to reward both short-term performance and long-term strategic success.

How to Apply

If you are an experienced regulatory leader with a proven track record in the medical device industry, we invite you to apply for the Director of Regulatory Strategy – EU MDR Devices role in Jacksonville, FL. This is a unique opportunity to lead regulatory efforts for a fast-growing company and ensure successful market access and compliance with the European Union Medical Device Regulation (EU MDR).

To apply, please submit your resume and a cover letter that highlights your experience in regulatory affairs within the medical device sector. Specifically, detail your expertise with EU MDR, regulatory strategy development, managing regulatory submissions, and navigating the complexities of post-market surveillance. Be sure to showcase your ability to drive operational excellence, engage with stakeholders, and maintain compliance with evolving industry standards.

This role offers a high-impact career opportunity where you will play a key role in the company’s growth, ensuring regulatory compliance and market expansion. If you are ready to shape the future of medical devices and drive regulatory excellence, apply today to take the next step in your career as a Director of Regulatory Strategy – EU MDR Devices!

For more information or to explore similar opportunities, visit our Regulatory Affairs Executive Recruiters Page.

Job Category: EU MDR Devices

Job Type: Full Time

Job Location: Jacksonville

Director of Regulatory Strategy – Jacksonville, FL | EU MDR Devices