Director of Labeling Compliance – Miami, FL | Medical Devices

Director of Labeling Compliance – Miami, FL | Medical Devices

A well-established medical device company in Miami, FL, is looking for a Director of Labeling Compliance to oversee the regulatory and compliance aspects of their product labeling operations. This role is pivotal to ensuring that the company’s products adhere to all labeling regulations, both domestically and internationally. The ideal candidate will bring extensive experience in regulatory affairs, particularly in the medical device sector, and have a strong understanding of FDA, ISO, and other regulatory guidelines.

Shape the Future of Medical Device Labeling Compliance

In this leadership position, you will be responsible for directing the labeling compliance strategies for a global medical device manufacturer. The Director of Labeling Compliance will work closely with cross-functional teams to ensure that product labeling meets all regulatory standards while aligning with the company’s quality objectives. If you are an expert in medical device regulations with a passion for ensuring compliance, this is an exceptional opportunity to drive the success and growth of a leading medical device company.

Key Responsibilities of the Director of Labeling Compliance – Medical Devices

Regulatory Compliance Management: Oversee the company’s labeling compliance efforts, ensuring adherence to global regulatory standards including FDA, ISO, and other industry-specific guidelines. Stay up-to-date with evolving regulations and ensure that labeling complies with legal and market requirements in all regions where products are sold.

Labeling Strategy Development: Develop and execute comprehensive labeling strategies that meet the needs of the medical device market. Collaborate with cross-functional teams, including R&D, marketing, and regulatory affairs, to ensure accurate, clear, and compliant product labels that reflect the company’s brand and meet consumer expectations.

Cross-Functional Collaboration: Work closely with product development, regulatory, legal, and quality assurance teams to ensure that all labeling content is aligned with regulatory standards and internal policies. Ensure that labeling content is accurate, detailed, and supports the company’s product claims and marketing strategies.

Compliance Documentation & Reporting: Manage the preparation, review, and submission of labeling documentation for regulatory authorities. Maintain thorough records of labeling changes and decisions to ensure compliance during audits and inspections.

Risk Mitigation & Issue Resolution: Identify potential labeling issues and regulatory risks, proactively addressing concerns before they impact product approvals or distribution. Lead efforts to resolve any non-compliance issues that arise during audits, inspections, or from customer feedback.

Global Labeling Strategy Implementation: Oversee the creation and management of global labeling strategies that comply with international regulations while ensuring consistency across regions. Coordinate with international teams to support the global launch and distribution of medical devices.

Labeling Training & Development: Lead training initiatives to ensure all team members are well-versed in regulatory requirements and best practices related to medical device labeling. Foster continuous improvement and development within the labeling compliance team.

Labeling Innovation & Improvement: Continuously assess and improve labeling processes to ensure efficiency, accuracy, and alignment with the latest regulatory developments. Implement technology and tools that streamline labeling workflows and enhance compliance management.

Stakeholder Communication & Reporting: Regularly communicate with senior leadership, regulatory agencies, and key stakeholders about the status of labeling compliance, any emerging issues, and ongoing improvements in the labeling process.

Ethical Standards & Risk Management: Uphold high ethical standards in all labeling practices, ensuring that labeling is truthful, non-misleading, and compliant with applicable regulations. Mitigate labeling risks through proactive risk management practices and thorough audits.

What the Client is Looking for in You

As the Director of Labeling Compliance – Medical Devices, the client is seeking an experienced and detail-oriented professional who can lead their labeling compliance efforts with a high level of expertise. You should possess a deep understanding of medical device regulations and have a proven ability to ensure labeling accuracy and compliance in a dynamic, regulated industry.

Proven Expertise in Medical Device Regulations

The client is looking for a leader with substantial experience in medical device labeling and regulatory compliance. You should have a strong track record of managing labeling processes that comply with FDA, ISO, and other regulatory standards. Experience in overseeing labeling submissions, managing audits, and navigating regulatory challenges is essential for success in this role.

In-Depth Knowledge of Global Labeling Standards

You must demonstrate the ability to manage labeling compliance across multiple regions and countries, ensuring adherence to global regulations. The ideal candidate will have experience in coordinating international labeling strategies and navigating the complexities of global regulatory requirements in the medical device industry.

Exceptional Attention to Detail and Accuracy

Given the high stakes of medical device labeling, the client is seeking someone with impeccable attention to detail and a commitment to accuracy. You should be able to oversee the development and review of labeling materials to ensure they meet all legal, ethical, and regulatory standards while reflecting the company’s brand values.

Strong Leadership and Cross-Functional Collaboration Skills

As Director of Labeling Compliance, you will lead a team and collaborate with various departments, including regulatory affairs, quality assurance, marketing, and R&D. The client values leaders who can motivate and manage a high-performing team while maintaining strong communication and collaboration across departments to achieve compliance goals.

Strategic Problem-Solving and Risk Management

You should possess strong problem-solving skills, with the ability to address labeling challenges proactively and mitigate risks before they impact product distribution. Experience in managing compliance-related issues and leading corrective actions is highly valued. The ideal candidate will have the ability to anticipate regulatory changes and adjust strategies accordingly.

Excellent Communication and Stakeholder Management

Effective communication is critical to this role. The client seeks a leader who can clearly communicate complex regulatory information to internal stakeholders, regulatory bodies, and external partners. You should have experience presenting compliance data and strategies to senior leadership and working with regulatory agencies to ensure smooth product approvals.

Commitment to Continuous Improvement

The client is looking for a Director who is committed to continuous improvement. You should be proactive in identifying opportunities to streamline labeling processes, enhance compliance efficiency, and stay ahead of industry trends. The ideal candidate will bring innovation to labeling practices while ensuring full regulatory adherence.

Dedication to Ethical Standards and Quality Control

Lastly, the client values a leader who upholds the highest ethical standards in all aspects of labeling and compliance. You should have a strong commitment to quality control, regulatory adherence, and maintaining the integrity of the company’s labeling practices, ensuring they align with both industry regulations and consumer safety standards.

FAQs About the Role – Director of Labeling Compliance – Medical Devices

1. What are the key responsibilities of the Director of Labeling Compliance in this role?

As the Director of Labeling Compliance, you will oversee the development and management of all labeling activities to ensure compliance with regulatory requirements in the medical device industry. You will lead the development of labeling strategies, collaborate with cross-functional teams, manage regulatory submissions, and mitigate labeling risks. Your role will also involve ensuring adherence to global labeling standards, overseeing audits, and maintaining compliance with regulatory bodies such as the FDA and ISO.

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

The ideal candidate should have significant experience in medical device labeling and regulatory compliance, with a strong understanding of FDA regulations, ISO standards, and other relevant global guidelines. A background in regulatory affairs, quality assurance, or a similar field is highly preferred. Experience leading cross-functional teams, managing labeling submissions, and ensuring compliance with regulatory standards is essential. A degree in life sciences, regulatory affairs, or a related field is required, and certification in regulatory affairs (e.g., RAC) is a plus.

3. What leadership qualities are essential for this role?

The client is looking for a detail-oriented and strategic leader with a proven track record of managing labeling compliance in the medical device industry. Key qualities include strong problem-solving abilities, excellent communication skills, the ability to manage complex projects, and a deep understanding of regulatory requirements. A collaborative mindset, attention to detail, and the ability to lead and mentor a compliance team are essential for success in this role.

4. What challenges can I expect in this role?

In this role, you will face challenges such as staying ahead of changing global regulations, ensuring timely submission of labeling materials, and addressing complex compliance issues across different regions. The ability to manage labeling risks, resolve compliance gaps, and ensure that products meet regulatory requirements without delays will be critical. Additionally, managing relationships with regulatory agencies and ensuring consistent quality across all labeling processes can pose challenges.

5. What is the expected impact of the Director of Labeling Compliance on the company’s success?

The Director of Labeling Compliance will have a direct impact on the company’s ability to successfully launch products, maintain regulatory approval, and uphold the company’s reputation in the medical device industry. By ensuring all labeling is accurate, compliant, and aligns with regulatory standards, you will contribute to the company’s operational efficiency, risk management, and overall product success in global markets.

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

The company fosters a collaborative, high-performance environment where innovation, compliance, and quality are prioritized. As a Director, you will be part of a team that values attention to detail, continuous improvement, and the importance of maintaining regulatory standards. The culture emphasizes teamwork, transparency, and the shared goal of delivering safe, compliant medical devices to the market.

What Remuneration Can You Expect from This Job?

As the Director of Labeling Compliance in the medical device industry based in Miami, FL, you can expect a competitive compensation package designed to attract top talent with the expertise necessary for regulatory compliance and medical device standards. The remuneration for this role typically includes:

1. Base Salary

The base salary for a Director of Labeling Compliance varies depending on company size, market position, and the level of experience required. In this industry, the annual base salary typically ranges from $130,000 to $180,000. Larger organizations or those with complex international operations may offer higher salaries.

2. Performance-Based Bonuses

Many medical device companies offer performance-based bonuses as part of their compensation packages. These bonuses are usually tied to key metrics such as regulatory milestones, compliance achievements, successful product launches, and operational efficiency. Bonus percentages typically range from 15% to 30% of the base salary, depending on individual and company performance.

3. Equity & Stock Options

Some medical device companies provide equity-based incentives, such as stock options or restricted stock units (RSUs), to align the Director’s interests with long-term company performance. These incentives can be a significant portion of the overall compensation package, particularly in larger or publicly traded companies.

4. Profit-Sharing & Long-Term Incentive Plans (LTIPs)

A few companies may offer profit-sharing or long-term incentive plans (LTIPs) to Directors. These programs reward performance over multiple years and ensure the leadership team focuses on long-term growth and regulatory success, providing additional financial incentives based on company profitability and strategic milestones.

5. Executive Benefits & Perks

Alongside salary and bonuses, many companies offer comprehensive benefits packages to executives, including:

• Health, dental, and vision insurance
• 401(k) or pension plans with company contributions
• Executive retirement plans
• Relocation assistance (if applicable)
• Wellness programs
• Expense accounts for business development and compliance-related activities

6. Signing Bonuses & Relocation Assistance

For highly qualified candidates, signing bonuses or relocation packages may be offered to attract top talent. These one-time incentives typically range from $20,000 to $50,000, depending on the candidate’s experience and the company’s need to fill the position quickly.

Total Compensation Potential

When factoring in base salary, bonuses, stock options, and benefits, the total compensation for a Director of Labeling Compliance in the medical device industry typically ranges from $160,000 to $250,000 annually. In larger or globally recognized companies, total compensation packages can exceed this range, especially with equity and performance-based incentives.

How to Apply

If you are an experienced, strategic leader with a proven track record in the medical device industry, we invite you to apply for the Director of Labeling Compliance position based in Miami, FL. This is a unique opportunity to shape the future of medical device labeling compliance, ensuring adherence to regulations while driving product excellence and operational efficiency.

To apply, please submit the following:

• Resume: Provide a detailed summary of your professional background, including your experience in regulatory compliance, medical device labeling, and your success in leading compliance strategies within the medical device industry.
• Cover Letter: Highlight your expertise in ensuring regulatory compliance across diverse markets, your ability to lead teams in labeling and packaging processes, and your experience in managing cross-functional teams. Also, share how you have contributed to the success of regulatory and labeling initiatives in your previous roles.

This role offers a high-impact opportunity to influence the company’s growth and success by ensuring compliance with industry standards and regulations, playing a critical role in product quality and safety.

Apply today to take the next step in your career and join a company that values innovation and excellence in regulatory and labeling practices.

For more information or to explore similar opportunities, visit our Medical Device Executive Careers page.

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Director of Labeling Compliance | Medical Device Jobs | Regulatory Compliance | Labeling & Packaging | Medical Device Industry | FDA Compliance | Labeling Strategy | Regulatory Leadership | Miami Careers