Director of Product Risk Management – St. Petersburg, FL | Class III Devices

Director of Product Risk Management – St. Petersburg, FL | Class III Devices

Are you an expert in product risk management with a focus on Class III medical devices? We are looking for a Director of Product Risk Management to join a leading company in St. Petersburg, FL. This is an exciting opportunity for a strategic leader to guide product safety, ensure regulatory compliance, and drive risk mitigation strategies in the medical device industry. If you have a deep understanding of risk management frameworks and are passionate about improving patient safety, this role is for you.

Lead Risk Management for Class III Devices in St. Petersburg

A top-tier organization in St. Petersburg, FL, is seeking a Director of Product Risk Management to oversee the safety and regulatory aspects of its Class III medical devices. The successful candidate will bring expertise in risk assessment, cross-functional collaboration, and regulatory requirements. If you have a strong track record in managing risk for high-complexity medical devices and a commitment to advancing safety standards, this is your opportunity to shape the future of the company and the industry.

Key Responsibilities of the Director of Product Risk Management – Class III Devices

Risk Management Leadership
Lead the development and implementation of comprehensive risk management strategies for Class III medical devices. Oversee risk identification, assessment, and mitigation strategies to ensure product safety and regulatory compliance throughout the product lifecycle.

Regulatory Compliance & Safety Standards
Ensure compliance with all applicable regulations, including FDA, ISO, and other global standards for Class III devices. Stay current with evolving regulatory requirements and ensure that products meet all safety, quality, and performance standards before market release.

Cross-Functional Collaboration
Work closely with R&D, product development, quality assurance, regulatory affairs, and manufacturing teams to integrate risk management into all aspects of product development and operations. Provide expert guidance to ensure risk mitigation is embedded in design and manufacturing processes.

Risk Assessment & Mitigation
Conduct thorough risk assessments and lead root cause analysis of any product-related incidents. Implement proactive measures to reduce risks, including hazard analysis and failure mode effects analysis (FMEA), to ensure the safety and efficacy of Class III devices.

Product Safety & Incident Response
Oversee the monitoring of product performance post-market, ensuring timely identification and resolution of safety concerns. Manage product recalls and corrective actions, ensuring compliance with all regulatory requirements and maintaining a strong safety record.

Quality Control & Continuous Improvement
Implement and maintain robust quality control processes for all products under risk management oversight. Lead continuous improvement initiatives by identifying trends in risk data and proposing corrective actions to enhance product quality and safety.

Stakeholder Communication & Reporting
Provide regular updates to senior leadership, regulatory bodies, and external stakeholders regarding product risk profiles, mitigation strategies, and compliance status. Prepare detailed risk management reports and documentation for audits and regulatory inspections.

Training & Development
Develop and deliver training programs on risk management best practices, regulatory requirements, and safety protocols for internal teams. Foster a culture of risk awareness and continuous learning within the organization.

Risk Budgeting & Resource Allocation
Manage the risk management budget, ensuring adequate resources are allocated to risk mitigation activities. Prioritize initiatives based on risk impact and ensure cost-effective solutions are implemented.

Supplier & Vendor Management
Collaborate with suppliers and vendors to assess and manage the risks associated with external products and services. Ensure that third-party suppliers comply with company safety standards and regulatory requirements, mitigating any potential risks in the supply chain.

What the Client is Looking for in You

As the Director of Product Risk Management – Class III Devices, the client is seeking a strategic, detail-oriented leader with a strong background in managing product risk for high-complexity medical devices. The ideal candidate will have a proven track record of ensuring safety, compliance, and risk mitigation for Class III devices, with a keen ability to navigate the complexities of the medical device industry while maintaining a patient-first mindset.

Extensive Experience in Product Risk Management

The client is looking for a seasoned risk management expert with significant experience working with Class III medical devices. You should have a deep understanding of regulatory requirements, risk assessment methodologies, and compliance standards. The client values a leader who has successfully led product risk management efforts, minimized risks, and enhanced product safety across the lifecycle of high-complexity devices.

Strategic Problem-Solver with a Focus on Safety

As the Director of Product Risk Management, you will be expected to make critical decisions that influence the safety and efficacy of the company’s products. The ideal candidate will demonstrate the ability to think strategically, develop risk mitigation plans, and integrate risk management strategies into the product development process. The client values candidates who can anticipate potential risks and implement effective solutions proactively.

Strong Technical & Regulatory Expertise

A deep understanding of regulatory requirements, such as FDA regulations, ISO standards, and other relevant global standards, is essential. The client seeks someone with strong technical expertise who can lead risk assessments, hazard analysis, and failure mode effects analysis (FMEA). You should be able to ensure the company’s products meet regulatory standards while maintaining the highest levels of safety and quality.

Exceptional Cross-Functional Leadership

The client is looking for a leader who can collaborate effectively across teams, from R&D to manufacturing, quality assurance, and regulatory affairs. You should be able to communicate complex risk information clearly and work with diverse teams to implement best practices in risk management. Experience in leading cross-functional teams and fostering collaboration in a fast-paced environment is highly valued.

Data-Driven Decision Maker

The ability to analyze risk data, make informed decisions, and communicate results clearly to senior leadership and stakeholders is critical. The client values a leader who uses data-driven insights to guide risk management strategies and ensures that all risk mitigation actions align with the company’s broader goals of safety, quality, and compliance.

Commitment to Regulatory Compliance and Quality Assurance

The client places high importance on maintaining the highest standards of regulatory compliance and product quality. You should have a proven ability to lead efforts in ensuring full compliance with regulatory agencies and quality control processes. A strong understanding of how to manage compliance risks and integrate quality assurance throughout the product lifecycle is essential.

Proven Track Record in Risk Mitigation for Class III Devices

The ideal candidate will have a track record of successfully managing the risks associated with Class III medical devices, including identifying potential hazards and implementing corrective actions. Your experience in leading incident investigations, root cause analyses, and post-market surveillance will be crucial in ensuring the safety and effectiveness of the products.

FAQs About the Role – Director of Product Risk Management – Class III Devices

1. What are the key responsibilities of the Director of Product Risk Management in this role?

As the Director of Product Risk Management, you will lead risk management strategies for Class III medical devices, ensuring product safety and regulatory compliance throughout the product lifecycle. You will oversee risk assessments, hazard analysis, and mitigation strategies. Additionally, you will collaborate with cross-functional teams, manage post-market surveillance, and ensure compliance with regulatory requirements. Your role will also include providing leadership in product safety, quality control, and incident response.

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

The ideal candidate should have extensive experience in risk management within the medical device industry, particularly with Class III devices. A strong background in regulatory compliance, quality assurance, and product safety is essential. You should be well-versed in FDA regulations, ISO standards, and risk analysis techniques such as FMEA. A degree in engineering, life sciences, or a related field is preferred, along with relevant certifications in risk management. Experience in managing product safety and leading risk management initiatives for complex devices is crucial.

3. What leadership qualities are essential for this role?

The client is looking for a leader with strong problem-solving skills, attention to detail, and the ability to make data-driven decisions. You should possess excellent communication and collaboration skills to work effectively with cross-functional teams, senior leadership, and regulatory bodies. The ability to influence and drive risk management practices across the organization is essential, as is a commitment to product safety and continuous improvement.

4. What challenges can I expect in this role?

In this role, you will face challenges related to the complexity of Class III medical devices, evolving regulatory requirements, and ensuring ongoing compliance throughout the product lifecycle. Managing product safety while addressing potential risks, mitigating post-market issues, and ensuring timely incident response will be key challenges. Additionally, staying ahead of regulatory changes and aligning risk management strategies with business objectives can require agility and foresight.

5. What is the expected impact of the Director of Product Risk Management on the company’s success?

The Director of Product Risk Management will have a direct impact on the safety, compliance, and reputation of the company’s Class III medical devices. By leading effective risk management strategies, ensuring regulatory compliance, and enhancing product safety, you will help maintain high standards for the company’s products. Your work will contribute to minimizing risks, ensuring product quality, and supporting long-term business success in the medical device industry.

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

The company fosters a culture of collaboration, safety, and continuous improvement. They value innovation and encourage teams to proactively address challenges and mitigate risks. You will be working in a dynamic, fast-paced environment with a strong focus on compliance and quality. As the Director of Product Risk Management, you will play a key role in shaping the company’s commitment to product excellence and safety while driving a culture of accountability across teams.

What Remuneration Can You Expect from This Job?

As the Director of Product Risk Management – Class III Devices in St. Petersburg, FL, you can expect a highly competitive and comprehensive compensation package. The remuneration for this role is designed to attract experienced professionals with a strong background in product risk management and medical device safety. Here’s what you can expect:

1. Base Salary

The base salary for this role varies depending on the company’s size, revenue, and the complexity of the products managed. For a Director of Product Risk Management in the Class III device sector, the annual base salary typically ranges from $130,000 to $200,000. Companies in more competitive markets or those with larger portfolios may offer higher salaries.

2. Performance-Based Bonuses

In addition to the base salary, performance-based bonuses are common in executive compensation packages. These bonuses are tied to key performance indicators (KPIs) such as risk mitigation success, regulatory compliance, and overall product safety. Bonuses can range from 20% to 40% of the base salary, depending on the achievement of company and individual goals.

3. Equity & Stock Options

Many companies in the medical device sector offer equity incentives as part of the total compensation package. This could include stock options or restricted stock units (RSUs), allowing you to share in the long-term success of the company. These equity options are aligned with company growth and may be a substantial part of the total remuneration.

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

Some organizations offer profit-sharing or LTIPs that reward long-term performance and success. These plans ensure that leadership focuses on the company’s sustained growth, offering additional financial rewards for meeting long-term business objectives.

5. Executive Benefits & Perks

As a senior leader in the medical device industry, you will also receive an attractive benefits package, which may include:

• Comprehensive health, dental, and vision insurance
• 401(k) or pension plans with company contributions
• Executive retirement planning options
• Company-provided vehicle or travel allowances
• Wellness programs designed for senior executives
• Expense accounts for business-related travel and development

6. Signing Bonuses & Relocation Assistance

For highly qualified candidates, the company may offer a signing bonus and/or relocation assistance to facilitate your transition into the role. Signing bonuses can range from $20,000 to $100,000, depending on the candidate’s experience and the company’s compensation strategy.

Total Compensation Potential

When factoring in the base salary, performance bonuses, equity, and other incentives, the total compensation for a Director of Product Risk Management in the Class III device space can range from $180,000 to $300,000 or more annually. In high-growth companies or those with a robust product portfolio, compensation packages could exceed this range.

How to Apply

If you are an experienced leader with a deep understanding of product risk management, specifically in Class III medical devices, we invite you to apply for the Director of Product Risk Management – Class III Devices role in St. Petersburg, FL. This is an exciting opportunity to join a high-impact team and play a critical role in driving product safety, risk mitigation, and regulatory compliance.

To apply, please submit the following:

1. Resume: Detailing your experience in product risk management, particularly within the medical device sector, including your leadership roles, key achievements, and expertise in Class III devices.
2. Cover Letter: Highlighting your strategic approach to risk management, your ability to lead cross-functional teams, and your experience with product safety, regulatory compliance, and risk assessment in the medical device industry.

In your application, we encourage you to emphasize your experience in managing complex product risk initiatives, ensuring regulatory compliance, and contributing to the development and launch of Class III devices.

This role offers an outstanding opportunity to make a significant impact on patient safety and product excellence in the medical device sector. Apply today to take the next step in your career as Director of Product Risk Management – Class III Devices in St. Petersburg, FL!

For more information or to explore similar opportunities, visit our Medical Device Leadership Page.

Tags:
Product Risk Management | Director of Risk Management | Medical Device Leadership | Class III Devices | Regulatory Compliance | Product Safety | Risk Assessment | Medical Device Industry | Risk Mitigation Strategies