Director of Regulatory Submissions (Med Device) in Orlando, FL

Are you a regulatory expert with a deep understanding of the medical device industry and a passion for navigating complex approval processes? We are seeking a Director of Regulatory Submissions (Med Device) in Orlando, FL, to lead the preparation, submission, and management of regulatory filings for medical device products in global markets. This executive role requires a detail-oriented professional with experience in FDA, EU MDR, and other international regulatory frameworks.

As the Director of Regulatory Submissions (Med Device) in Orlando, FL, you will oversee all aspects of regulatory submission strategies, ensuring compliance with evolving global regulations. You will work closely with cross-functional teams, including R&D, quality assurance, and clinical affairs, to streamline submission processes and facilitate timely product approvals. If you have a track record of successfully managing regulatory submissions for medical devices and thrive in a fast-paced environment, we encourage you to apply.

About This Role

The Director of Regulatory Submissions (Med Device) in Orlando, FL, plays a crucial role in ensuring medical device products meet regulatory requirements for market entry. This position involves overseeing submission strategies, managing regulatory documentation, and liaising with regulatory agencies such as the FDA, Health Canada, and EU regulatory bodies. You will lead a team responsible for preparing and submitting 510(k)s, PMAs, De Novo applications, CE Mark dossiers, and other global regulatory filings.

Success in this role requires a keen eye for regulatory trends, the ability to interpret complex regulations, and the skills to develop proactive submission strategies that align with business objectives. As the Director of Regulatory Submissions (Med Device) in Orlando, FL, you will be instrumental in accelerating product approvals, minimizing regulatory risks, and ensuring the company remains compliant with ever-changing medical device regulations.

Key Responsibilities – Director of Regulatory Submissions (Med Device) in Orlando, FL

Develop and Implement Regulatory Submission Strategies

Create comprehensive regulatory submission plans for new and existing medical device products.
Stay updated on evolving global regulatory requirements to ensure compliance.
Collaborate with internal stakeholders to align regulatory strategies with business goals.

Prepare and Submit Regulatory Filings

Lead the preparation and submission of 510(k)s, PMAs, De Novo applications, and CE Mark dossiers.
Ensure accuracy, completeness, and compliance of all regulatory submissions.
Work closely with regulatory agencies to address inquiries and ensure smooth approval processes.

Oversee Global Regulatory Compliance

Ensure all medical device products comply with FDA, EU MDR, Health Canada, and international regulations.
Implement regulatory best practices and processes to enhance submission efficiency.
Monitor post-market regulatory requirements and ensure ongoing compliance.

Lead Cross-Functional Regulatory Collaboration

Partner with R&D, quality assurance, clinical affairs, and legal teams to gather necessary data for submissions.
Provide regulatory guidance on product development and lifecycle management.
Ensure cross-functional teams understand and adhere to regulatory requirements.

Manage Regulatory Risk and Issue Resolution

Identify potential regulatory risks early in the product development process.
Develop risk mitigation strategies to prevent submission delays.
Address regulatory challenges proactively and work with agencies to resolve issues efficiently.

Ensure Timely Approvals and Market Entry

Drive submission timelines to ensure medical devices reach the market efficiently.
Anticipate potential bottlenecks and implement solutions to accelerate approvals.
Coordinate with global regulatory agencies to facilitate smooth product launches.

Track and Analyze Regulatory Trends

Monitor changes in medical device regulations and assess their impact on submissions.
Provide leadership with insights on emerging regulatory challenges and opportunities.
Develop training programs to keep internal teams informed about regulatory updates.

Lead and Develop the Regulatory Submissions Team

Manage and mentor a team of regulatory professionals.
Foster a culture of continuous improvement and regulatory excellence.
Provide training and career development opportunities for regulatory team members.

What The Client is Looking For in You

To succeed as the Director of Regulatory Submissions (Med Device) in Orlando, FL, you need a strong regulatory background, leadership skills, and the ability to navigate complex medical device approval processes. The ideal candidate will possess:

Extensive Regulatory Experience in the Medical Device Industry – A deep understanding of FDA regulations, EU MDR requirements, and global medical device submission processes.
Proven Success in Managing Regulatory Submissions – A history of preparing and submitting 510(k)s, PMAs, De Novo applications, and CE Mark dossiers with successful approvals.
Strong Analytical and Strategic Thinking Skills – The ability to interpret evolving regulatory landscapes and develop proactive submission strategies.
Detail-Oriented and Process-Driven Approach – A meticulous focus on regulatory documentation, submission timelines, and compliance requirements.
Effective Communication and Regulatory Liaison Skills – Experience in directly interacting with FDA, notified bodies, and other regulatory agencies to facilitate approvals.
Leadership and Team Management Experience – Ability to lead and mentor a regulatory team, fostering a culture of compliance, collaboration, and continuous improvement.
Adaptability and Problem-Solving Ability – Capable of overcoming regulatory challenges and streamlining submission processes to meet business objectives.
Educational and Professional Qualifications – A bachelor’s or master’s degree in regulatory affairs, life sciences, biomedical engineering, or a related field, along with 10+ years of experience in medical device regulatory affairs.

Why This Opportunity Stands Out

This role offers a unique opportunity to be at the forefront of regulatory innovation in the medical device industry. As the Director of Regulatory Submissions (Med Device) in Orlando, FL, you will:

Play a Crucial Role in Product Approvals – Be directly responsible for ensuring that life-changing medical technologies reach the market.
Join a High-Growth Medical Device Company – Work with a company that is expanding its global presence and developing cutting-edge medical devices.
Competitive Compensation and Benefits – Receive a highly competitive salary, performance-based incentives, and executive-level benefits.
Lead Regulatory Strategy and Innovation – Take ownership of submission processes and influence how regulatory compliance is integrated into product development.
Work in a Collaborative and Dynamic Environment – Join a team that values innovation, regulatory excellence, and professional growth.
Make a Lasting Impact – Help shape the future of medical device compliance and contribute to bringing innovative healthcare solutions to patients worldwide.

FAQs About the Role

Q: What industries should I have experience in?
A: Candidates must have a strong regulatory background in the medical device industry, including experience with FDA, EU MDR, and other international submission processes.

Q: What types of regulatory submissions will I be handling?
A: This role involves preparing and managing 510(k) submissions, PMAs, De Novo applications, CE Mark dossiers, and other global regulatory filings.

Q: What is the reporting structure for this role?
A: The Director of Regulatory Submissions (Med Device) in Orlando, FL will report directly to the Vice President of Regulatory Affairs and collaborate closely with cross-functional teams.

Q: Does this position require travel?
A: Yes, occasional domestic and international travel may be required for regulatory meetings, conferences, and interactions with global regulatory agencies.

Q: What qualifications are required for this role?
A: A bachelor’s or master’s degree in regulatory affairs, life sciences, biomedical engineering, or a related field, along with 10+ years of experience in medical device regulatory affairs, is required.

Q: What type of leadership experience is expected?
A: Candidates should have experience in managing and mentoring a regulatory team, ensuring high standards for compliance and submission processes.

Q: What is the expected timeline for hiring?
A: The company aims to fill this position within the next 60–90 days, with onboarding focused on aligning regulatory strategies and submission priorities.

Q: How does this role contribute to the company’s success?
A: The Director of Regulatory Submissions (Med Device) in Orlando, FL plays a critical role in securing timely approvals, minimizing regulatory risks, and ensuring medical devices reach the market efficiently.

What Remuneration Can You Expect from This Job?

As the Director of Regulatory Submissions (Med Device) in Orlando, FL, you can expect a highly competitive compensation package that reflects your expertise and leadership in regulatory affairs. The total remuneration includes:

Base Salary – A competitive six-figure base salary aligned with industry standards, experience, and qualifications.
Performance-Based Bonuses – Annual performance incentives tied to successful regulatory submissions, compliance achievements, and company growth milestones.
Stock Options & Equity – Depending on the company’s structure, eligible candidates may receive equity grants or stock options, allowing them to benefit from the company’s long-term success.
Comprehensive Benefits Package – Including health, dental, and vision insurance, as well as flexible spending accounts (FSAs) and health savings accounts (HSAs).
Retirement & Financial Planning – Access to 401(k) plans with employer contributions and financial wellness programs.
Paid Time Off & Work-Life Balance – Generous PTO, paid holidays, and flexible work arrangements to support work-life balance.
Professional Development Support – Funding for certifications, industry conferences, and continued education to advance your career.

Overall, this role offers a highly rewarding compensation package designed to attract top regulatory talent and recognize the impact of regulatory leadership on medical device success.

How to Apply for This Director of Regulatory Submissions (Med Device) Position in Orlando, FL

If you are an experienced regulatory professional with a strong background in medical device submissions, we invite you to apply for the Director of Regulatory Submissions (Med Device) in Orlando, FL. This is an excellent opportunity to lead regulatory strategies, oversee FDA submissions, and drive compliance initiatives within a fast-growing medical device company.

To apply, please submit your resume and a cover letter detailing your experience in regulatory affairs, FDA submissions, and compliance leadership.

This role offers a unique opportunity to be at the forefront of regulatory innovation while shaping the success of groundbreaking medical device products. Apply today to take the next step in your career as a Director of Regulatory Submissions (Med Device) in Orlando, FL.

For more information or to explore similar opportunities, visit our Medical Device Regulatory Recruiters page.

Job Category: Director of Regulatory Submissions

Job Type: Full Time

Job Location: Orlando