Director of Global Regulatory Affairs – Orlando, FL | Medical Disposables

We are seeking an experienced and strategic Director of Global Regulatory Affairs to lead our regulatory initiatives for a leading medical disposables company in Orlando, FL. This key role offers the opportunity to ensure compliance, manage global regulatory strategies, and navigate complex international markets. If you are a forward-thinking professional with a strong understanding of regulatory requirements in the medical industry, this is your opportunity to influence the global landscape and drive the success of a growing organization.

Drive Global Regulatory Excellence in Medical Disposables

As the Director of Global Regulatory Affairs, you will play a crucial role in leading regulatory efforts across multiple regions, ensuring that our medical disposable products meet all necessary standards and regulations. This position demands a proven leader with extensive experience in medical device or disposables regulatory affairs, exceptional strategic thinking, and the ability to collaborate with cross-functional teams to achieve global market access. If you have a passion for compliance and want to make an impact in the ever-evolving medical industry, we want you to join our team in Orlando, FL.

Key Responsibilities of the Director of Global Regulatory Affairs – Medical Disposables

Global Regulatory Strategy: Lead the development and implementation of global regulatory strategies to ensure compliance with all applicable regulations across key markets. Collaborate with cross-functional teams to align regulatory efforts with business goals and market access needs.

Regulatory Compliance & Risk Management: Oversee regulatory submissions, approvals, and audits to ensure medical disposable products meet industry standards and regulations. Manage regulatory risks and provide guidance to mitigate compliance-related challenges across regions.

Market Access & Expansion: Identify and manage regulatory pathways for new product approvals and market entries, ensuring smooth global expansion. Work closely with product development and marketing teams to navigate regulatory landscapes in emerging and established markets.

Cross-Functional Collaboration: Collaborate with R&D, manufacturing, legal, and quality assurance teams to ensure seamless product development and regulatory approval processes. Provide regulatory guidance throughout the product lifecycle, from design to post-market surveillance.

Regulatory Affairs Leadership: Manage and mentor a team of regulatory professionals, fostering a culture of excellence, continuous learning, and compliance. Drive the development of talent and capabilities within the regulatory affairs department.

Regulatory Submissions & Approvals: Lead the preparation and submission of regulatory dossiers, ensuring that all required documentation is complete, accurate, and aligned with global standards. Stay current with evolving regulations to maintain product compliance.

Stakeholder & Industry Relations: Build and maintain strong relationships with regulatory authorities, industry associations, and other stakeholders. Represent the company in regulatory discussions, policy development, and industry forums to advocate for the company’s interests.

Post-Market Surveillance & Reporting: Oversee the monitoring of regulatory compliance post-market, ensuring products continue to meet safety and efficacy standards. Lead the preparation of reports and regulatory filings related to adverse events, product recalls, and market performance.

Innovation & Product Development Support: Provide regulatory input during the product development process to ensure compliance with international regulations, enabling smooth product launches. Guide the development of new medical disposable products while balancing innovation with regulatory requirements.

Regulatory Compliance Training: Lead training and awareness initiatives for internal teams on global regulatory requirements, ensuring staff are well-informed and compliant with changing regulations and industry best practices.

What the Client is Looking for in You

As the Director of Global Regulatory Affairs for Medical Disposables, the client is seeking an experienced, strategic, and results-oriented leader to drive the regulatory functions for a global medical disposable product line. The ideal candidate will possess a strong background in regulatory affairs, with a deep understanding of the medical device industry, and a proven track record of navigating complex regulatory environments across multiple regions.

Proven Expertise in Global Regulatory Affairs

The client is looking for a highly experienced regulatory professional with a robust understanding of global regulatory requirements and procedures. You should have a history of managing regulatory affairs for medical devices or disposables, overseeing successful product approvals, and ensuring compliance across multiple regions, including the EU, US, and emerging markets. Experience with international regulatory bodies such as the FDA, EMA, and Health Canada is highly desired.

Strategic Leadership and Vision

As the Director of Global Regulatory Affairs, you must be a strategic thinker who can anticipate market changes and adapt regulatory strategies accordingly. The client is seeking a leader who can create and implement long-term regulatory strategies, ensuring global market access while maintaining compliance. You should be adept at managing regulatory risks, ensuring smooth product launches, and navigating complex international markets.

Strong Communication and Cross-Functional Collaboration

The ability to collaborate effectively with cross-functional teams, including R&D, legal, manufacturing, and quality assurance, is critical for success in this role. The client values leaders who can communicate complex regulatory information clearly and work collaboratively with internal teams to achieve regulatory goals while fostering a culture of compliance and innovation.

In-Depth Knowledge of Regulatory Submissions and Approvals

A deep understanding of the regulatory submission process is essential. The client seeks someone who can successfully manage regulatory filings, ensuring accurate and timely submissions for new products, product modifications, and renewals. You should have experience leading global submissions and approvals, with a focus on maintaining compliance across various markets.

Exceptional Leadership and Team Management

The client is looking for someone who can lead and mentor a team of regulatory professionals, ensuring high performance and continuous development. You should have a proven track record of building strong, effective teams, fostering a culture of collaboration, innovation, and accountability, and driving the team to meet regulatory milestones and objectives.

Commitment to Compliance and Risk Management

The ideal candidate will be highly focused on ensuring regulatory compliance and managing risks associated with product safety, quality, and regulatory changes. You should have a comprehensive understanding of risk management processes and be able to identify, mitigate, and manage potential risks to the company’s regulatory standing and market access.

Global Perspective with Regional Expertise

Given the international scope of the role, the client is looking for a regulatory affairs leader with a global perspective and regional expertise. Experience managing regulatory affairs in key markets, including North America, Europe, and Asia, and navigating the nuances of regulatory frameworks in different regions will be essential in this role.

Commitment to Ethical Business Practices and Corporate Governance

The client values a leader who upholds the highest ethical standards and ensures the company complies with industry regulations, corporate governance, and ethical business practices. Your commitment to maintaining the company’s reputation and fostering a culture of compliance will be critical in this role.

FAQs About the Role – Director of Global Regulatory Affairs – Medical Disposables

What are the key responsibilities of the Director of Global Regulatory Affairs in this role?

As the Director of Global Regulatory Affairs, you will be responsible for developing and implementing global regulatory strategies, ensuring compliance with regulatory requirements across multiple markets. You will oversee regulatory submissions, approvals, and post-market surveillance, manage regulatory risks, and collaborate with cross-functional teams to drive product development and market expansion. Additionally, you will lead a team of regulatory professionals and maintain strong relationships with regulatory authorities, stakeholders, and industry associations.

What qualifications and experience are required for this position?

The ideal candidate should have extensive experience in regulatory affairs within the medical device or disposable products industry. You should have a proven track record of managing global regulatory submissions and approvals, with expertise in regulatory frameworks for key markets such as the FDA, EMA, and other international bodies. A degree in Life Sciences, Engineering, or a related field is required, and certifications such as RAC (Regulatory Affairs Certification) are a plus. Prior experience in leading regulatory affairs teams and working with cross-functional departments is essential.

What leadership qualities are essential for this role?

The client seeks a strategic, proactive leader with strong communication and decision-making skills. You should have the ability to navigate complex regulatory environments and inspire a regulatory team to achieve business goals. Strong problem-solving skills, attention to detail, and the ability to build effective relationships with cross-functional teams and external stakeholders are key. A commitment to compliance, ethical standards, and risk management is also essential.

What challenges can I expect in this role?

You will face challenges related to navigating evolving global regulatory landscapes, ensuring compliance across multiple markets, and managing regulatory risks. The role requires you to adapt to changes in regulatory policies, resolve complex issues in a timely manner, and oversee regulatory approvals for new product launches. Coordinating between different regions and meeting tight deadlines for product submissions and approvals can also be challenging.

What is the expected impact of the Director of Global Regulatory Affairs on the company’s growth?

The Director of Global Regulatory Affairs will have a significant impact on the company’s ability to expand into new markets and launch innovative products by ensuring timely and successful regulatory approvals. Your ability to manage the regulatory process efficiently and mitigate compliance risks will directly influence the company’s market access, profitability, and long-term success.

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

The company fosters a collaborative, dynamic, and compliance-driven culture. You will be part of a team that values continuous learning, innovation, and cross-functional collaboration. The work environment is fast-paced, with an emphasis on regulatory excellence and global expansion. The company encourages a strong focus on professional development and provides opportunities for growth within the organization.

What are the career development opportunities within this role?

As the Director of Global Regulatory Affairs, you will have the opportunity to expand your expertise in global regulatory affairs and grow into a more senior leadership role. The company is committed to investing in its employees’ growth, offering training programs, mentorship, and opportunities to work on high-profile international projects that will enhance your professional development.

What type of travel is expected in this role?

Given the global nature of this role, some travel may be required to attend regulatory meetings, conferences, or audits. The extent of travel will vary based on market expansion and regulatory requirements in key regions.

What support will I receive in this role?

You will receive support from a highly collaborative team across regulatory affairs, R&D, legal, quality assurance, and manufacturing. The company provides resources for continuous education and professional development to ensure you stay updated with global regulatory changes. Additionally, you will be supported by senior leadership in driving strategic decisions and meeting the company’s growth objectives.

What Remuneration Can You Expect from This Job?

As the Director of Global Regulatory Affairs – Medical Disposables in a leading organization, you can expect a highly competitive compensation package designed to attract top executive talent in the regulatory affairs domain. The remuneration for this role typically includes:

Base Salary
The base salary for a Director in Regulatory Affairs within the medical device or disposables industry typically ranges from $150,000 to $250,000 annually, depending on the size of the company, market position, and geographical location. Larger or more globally focused companies may offer higher base salaries.
Performance-Based Bonuses
In addition to the base salary, performance-based bonuses are common. These bonuses are typically tied to key performance indicators (KPIs) such as successful regulatory submissions, market expansions, and overall regulatory compliance performance. Bonuses can range from 20% to 50% of the base salary, depending on individual and company performance.
Equity & Stock Options
Many companies offer equity-based incentives such as stock options or performance shares to align executive compensation with the company’s long-term success. These incentives provide a stake in the company’s growth, with potential long-term financial rewards.
Profit-Sharing & Long-Term Incentive Plans (LTIPs)
Some companies provide profit-sharing programs or LTIPs, which are designed to reward sustained performance over multiple years. These plans ensure a focus on long-term success and financial stability, with additional incentives based on the company’s overall performance.
Executive Benefits & Perks
Executives typically receive comprehensive benefits, which may include:

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

Signing Bonuses & Relocation Assistance
To attract top candidates, signing bonuses and relocation assistance may be provided, especially for high-demand roles. Signing bonuses can range from $20,000 to $100,000, while relocation packages may include moving expenses, housing allowances, and other related costs, depending on the company’s policy.

Total Compensation Potential

When factoring in the base salary, bonuses, stock options, and other benefits, total compensation for a Director of Global Regulatory Affairs in medical disposables can range from $200,000 to $400,000 annually. For larger organizations or those with extensive international operations, total compensation could exceed this range, with significant long-term rewards based on company performance and equity incentives.

How to Apply

If you are an experienced leader with a proven track record in global regulatory affairs and medical disposables, we invite you to apply for the Director of Global Regulatory Affairs position in Orlando, FL. This is an exceptional opportunity to shape the regulatory landscape of a leading medical disposables company, ensuring compliance with global standards while driving innovation in product development and market expansion.

To apply, please submit the following:

Resume: Detailing your experience in regulatory affairs within the medical devices or disposables sector, including your expertise in managing regulatory submissions, compliance, and market strategy across multiple regions.
Cover Letter: Highlighting your leadership experience, strategic thinking, and accomplishments in regulatory affairs. Be sure to emphasize your ability to manage cross-functional teams, navigate complex regulatory landscapes, and maintain compliance in global markets.
Relevant Certifications or Degrees: If applicable, include any certifications or advanced degrees relevant to regulatory affairs or the medical devices industry.

This role offers a high-impact career opportunity, where you will contribute to the company’s global growth while ensuring its products meet the highest regulatory standards. If you are ready to take the next step in your regulatory affairs career, apply today!

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

Job Category: Medical Disposables

Job Type: Full Time

Job Location: Orlando

Director of Global Regulatory Affairs – Orlando, FL | Medical Disposables