Chief Compliance Officer – Port St. Lucie, FL | FDA-Regulated Devices

 

Chief Compliance Officer – Port St. Lucie, FL | FDA-Regulated Devices

Are you an experienced compliance leader with a deep understanding of FDA regulations and a commitment to ensuring industry standards are met? We are looking for a Chief Compliance Officer (CCO) to oversee regulatory affairs and compliance operations for a leading company in Port St. Lucie, FL, specializing in FDA-regulated devices. This is a key leadership role where you will drive compliance strategies, ensure product safety, and foster a culture of quality and integrity across the organization.

Lead Compliance in FDA-Regulated Devices

A prominent company in the medical device industry, based in Port St. Lucie, FL, is seeking a Chief Compliance Officer to lead its efforts in meeting FDA regulations and ensuring the highest standards of safety and quality. The ideal candidate will possess a strong background in FDA compliance, regulatory affairs, and risk management, with a proven ability to navigate the complexities of the medical device landscape. If you are ready to shape the compliance culture and safeguard the company’s reputation, this is the perfect opportunity to make a significant impact.

Key Responsibilities of the Chief Compliance Officer (CCO) – FDA-Regulated Devices

Regulatory Strategy Development:
Lead the creation and execution of a robust regulatory strategy that ensures full compliance with FDA regulations, industry standards, and company policies. Stay up to date with evolving regulatory requirements and industry best practices, ensuring the company meets all applicable guidelines for FDA-regulated devices.

Compliance Program Management:
Oversee the development, implementation, and monitoring of comprehensive compliance programs, including internal audits, risk assessments, and continuous improvement processes. Ensure that all products and business operations adhere to FDA guidelines, maintaining the highest standards of quality, safety, and integrity.

FDA Submissions & Approvals:
Manage and supervise the preparation and submission of regulatory filings, including 510(k), PMA, and other FDA-required documents. Ensure that all regulatory submissions are accurate, timely, and meet FDA expectations, securing approvals for new products and ongoing product compliance.

Risk Management & Mitigation:
Identify potential regulatory risks and develop strategies to mitigate them. Lead risk assessments and root cause analysis for any regulatory non-compliance issues, implementing corrective actions to prevent recurrence and ensure long-term regulatory adherence.

Cross-Departmental Collaboration:
Work closely with cross-functional teams, including R&D, quality assurance, legal, and manufacturing, to ensure compliance is integrated into all stages of product development and commercialization. Foster a culture of compliance throughout the organization, emphasizing quality and safety across all departments.

Training & Development:
Develop and implement training programs to ensure all employees are informed of FDA regulations and company compliance policies. Promote ongoing education and awareness to maintain a compliance-oriented organizational culture.

Regulatory Reporting & Documentation:
Maintain comprehensive records of regulatory activities, audits, inspections, and compliance certifications. Prepare and present regular reports to senior leadership, ensuring the company remains aligned with FDA requirements and standards.

Supplier & Vendor Compliance:
Ensure that suppliers and third-party vendors adhere to FDA regulations and company compliance standards. Conduct audits, establish compliance agreements, and manage relationships to maintain product quality and safety from sourcing through production.

Internal Audits & Continuous Improvement:
Lead regular internal audits and reviews to ensure compliance across all company operations. Implement continuous improvement strategies to enhance regulatory compliance, product quality, and operational efficiency.

Crisis Management & Recall Coordination:
In the event of a product recall or regulatory issue, manage the crisis response, ensuring prompt and thorough action to address the situation. Lead the coordination of recall activities, working closely with legal teams and regulatory authorities to resolve issues quickly and maintain compliance.

What the Client is Looking for in You

As the Chief Compliance Officer (CCO) – FDA-Regulated Devices, the client is seeking a highly skilled and experienced compliance leader with a deep understanding of FDA regulations and the medical device industry. You should be a strategic, detail-oriented professional capable of managing complex regulatory affairs while ensuring the company’s compliance with all FDA requirements. The ideal candidate will have a strong track record of leading compliance programs, mitigating risks, and fostering a culture of quality and safety.

Proven Expertise in FDA Regulations

The client is looking for a CCO with extensive experience in navigating the complexities of FDA regulations in the medical device industry. You should have a proven ability to ensure that the company’s products and operations meet FDA standards and other regulatory requirements. Expertise in FDA submissions, including 510(k) and PMA processes, is highly valued.

Strategic Leadership in Compliance & Risk Management

The ideal candidate will demonstrate a strategic approach to managing compliance and regulatory risks. You should be able to develop and implement effective compliance strategies that mitigate legal, operational, and financial risks while ensuring the highest standards of safety and quality. The ability to anticipate and respond to changing regulatory landscapes is critical to this role.

Strong Cross-Functional Collaboration

The CCO will be expected to work closely with cross-functional teams, including R&D, legal, manufacturing, and quality assurance. You should have the ability to collaborate effectively across departments, ensuring that compliance is integrated into every aspect of the product lifecycle, from development to commercialization. The client values leaders who can drive alignment and foster a culture of compliance across the organization.

Excellent Communication & Stakeholder Management

The client seeks a CCO who can effectively communicate complex regulatory requirements and compliance strategies to senior leadership, board members, and external stakeholders. You should be able to provide clear and concise updates, present data-driven insights, and build strong relationships with regulatory bodies, auditors, and external partners.

Ability to Lead Compliance Training & Culture Building

The ideal candidate will be a proactive leader who can develop and lead training programs that ensure all employees understand their compliance responsibilities. You should be able to create a culture of compliance throughout the organization, emphasizing ethical business practices, quality assurance, and safety.

Problem-Solving and Crisis Management Skills

In this role, you will be responsible for managing any regulatory challenges or crises that may arise, including product recalls and regulatory investigations. You should have strong problem-solving skills and the ability to respond swiftly and effectively in high-pressure situations, ensuring minimal disruption to operations and maintaining the company’s reputation.

Commitment to Quality and Ethical Operations

The client values a leader who demonstrates a deep commitment to quality and ethical operations. You should be able to ensure that all business activities are conducted in compliance with industry regulations and internal policies. Your focus on continuous improvement, risk mitigation, and regulatory adherence will be critical to the company’s long-term success and reputation in the FDA-regulated device industry.

FAQs About the Role – Chief Compliance Officer (CCO) – FDA-Regulated Devices

1. What are the key responsibilities of the Chief Compliance Officer (CCO) in this role?
   As the Chief Compliance Officer (CCO), you will be responsible for ensuring the company’s products and operations comply with FDA regulations and other relevant industry standards. You will lead the development and execution of the company’s regulatory strategy, manage compliance programs, conduct risk assessments, and oversee regulatory submissions. Additionally, you will collaborate with cross-functional teams to integrate compliance into all aspects of product development and operations, ensuring a culture of quality and safety.
2. What qualifications and experience are required for this position?
   The ideal candidate will have significant experience in regulatory compliance within the FDA-regulated medical device industry. A deep understanding of FDA regulations, such as 510(k), PMA, and other relevant frameworks, is essential. You should have experience in regulatory affairs, risk management, and compliance program development. A background in leading cross-functional teams, handling FDA inspections, and managing compliance in a fast-paced environment is highly valued. A degree in Life Sciences, Engineering, or a related field is preferred. Advanced certifications in regulatory affairs (e.g., RAC) are a plus.
3. What leadership qualities are essential for this role?
   The client seeks a leader who can think strategically and lead with integrity, ensuring that regulatory compliance is seamlessly integrated into all business operations. Key qualities include attention to detail, excellent communication skills, the ability to manage complex regulatory issues, and a commitment to fostering a culture of compliance across the organization. You should also be a strong collaborator, capable of engaging with senior leadership, regulatory bodies, and external stakeholders effectively.
4. What challenges can I expect in this role?
   As the CCO, you will face challenges such as navigating evolving FDA regulations, managing compliance risks, and maintaining product quality and safety while driving business growth. You will need to ensure timely and accurate regulatory submissions, address any non-compliance issues promptly, and maintain strong relationships with regulatory authorities. Additionally, handling complex legal and ethical compliance matters, especially during product development or recalls, will require quick decision-making and problem-solving skills.
5. What is the expected impact of the CCO on the company’s success?
   The CCO plays a critical role in ensuring the company’s products are compliant with regulatory standards, which directly impacts the company’s ability to market and sell FDA-regulated devices. Your leadership will ensure product safety, mitigate legal risks, and maintain the company’s reputation with regulators, investors, and customers. By maintaining a strong compliance program, you will help ensure the company’s continued success and ability to innovate within the regulated space.
6. What is the company’s culture and work environment like?
   The company fosters a collaborative and compliance-driven culture, where quality and safety are top priorities. They value transparency, accountability, and continuous improvement. The environment is fast-paced and dynamic, requiring adaptability and a proactive approach to regulatory challenges. As CCO, you will play a key role in shaping the company’s compliance culture, ensuring that all employees understand and uphold regulatory requirements at every level of the organization.

What Remuneration Can You Expect from This Job?

As the Chief Compliance Officer (CCO) – FDA-Regulated Devices, the compensation package is designed to attract highly skilled professionals with a proven track record in regulatory affairs. The remuneration for this role typically includes:

1. Base Salary
   The base salary for a Chief Compliance Officer in the FDA-regulated device industry varies based on the company’s size, market position, and geographic location. For this role, the annual base salary typically ranges from $150,000 to $250,000, with potential adjustments based on experience and company specifics.
2. Performance-Based Bonuses
   In addition to the base salary, most CCO compensation packages include performance-based bonuses. These bonuses are tied to key business outcomes, such as successful regulatory approvals, adherence to compliance standards, and overall company performance. Depending on individual and company results, these bonuses can range from 20% to 50% of the base salary.
3. Equity & Stock Options
   Many companies offer equity-based incentives to align executive compensation with long-term business success. As a CCO, you may be eligible for stock options, restricted stock units (RSUs), or performance shares. These incentives provide financial rewards based on the company’s growth and stock performance, potentially increasing the total compensation package significantly.
4. Profit-Sharing & Long-Term Incentive Plans (LTIPs)
   Some companies offer profit-sharing plans or LTIPs as part of their executive compensation structure. These plans reward the CCO for sustained performance over multiple years, focusing on long-term company growth, profitability, and shareholder value.
5. Executive Benefits & Perks
   In addition to the salary and bonuses, CCOs typically receive a comprehensive benefits package, which may include:
   • Health, dental, and vision insurance
   • 401(k) or pension plans with company contributions
   • Executive retirement plans
   • Travel allowances or company-provided vehicles
   • Executive wellness programs
   • Expense accounts for business development and networking
   • Paid time off and sick leave
6. Signing Bonuses & Relocation Assistance
   For highly experienced candidates, signing bonuses or relocation packages may be offered. These one-time incentives are designed to attract top-tier talent and can range from $25,000 to $100,000, depending on the company and the candidate’s qualifications.

Total Compensation Potential
When factoring in base salary, bonuses, stock options, and other incentives, the total compensation for a Chief Compliance Officer in FDA-regulated devices can range from $200,000 to over $400,000 annually, with potential for higher earnings based on company performance and executive incentives.

How to Apply

If you are a seasoned and strategic leader with a proven track record in the FDA-regulated devices sector, we invite you to apply for the Chief Compliance Officer (CCO) – FDA-Regulated Devices role. This is an exceptional opportunity to lead the compliance efforts of a high-growth company, drive regulatory excellence, and implement robust strategies to ensure product safety and adherence to industry standards.

To apply, please submit the following:

1. Your Resume – Detailing your professional experience in compliance leadership within FDA-regulated industries, including any specific accomplishments related to regulatory affairs, risk management, and quality assurance.
2. Cover Letter – In your cover letter, please outline your experience in managing compliance strategies, navigating FDA regulations, ensuring product safety, and leading teams within a highly regulated environment. Highlight your ability to drive compliance culture and your approach to mitigating regulatory risks.

This role offers a high-impact opportunity to shape the company’s regulatory framework, ensure compliance with industry standards, and contribute to long-term success. Apply today to take the next step in your career as a Chief Compliance Officer (CCO) – FDA-Regulated Devices!

For more information or to explore similar opportunities, visit our FDA-Regulated Devices Leadership Careers Page.

Tags:
Chief Compliance Officer | FDA-Regulated Devices | Regulatory Affairs Leadership | Compliance Strategy | Product Safety | Risk Management | FDA Regulations | Quality Assurance | Compliance Leadership