Director of Biocompatibility – Tampa, FL | Implantable Devices

We are looking for an experienced Director of Biocompatibility to join a cutting-edge implantable device company in Tampa, FL. This is a unique opportunity to oversee and advance the biocompatibility program for life-changing medical devices. As the Director, you will be responsible for ensuring the safety and effectiveness of implantable devices by leading biocompatibility testing, regulatory compliance, and strategic initiatives. If you have a passion for advancing medical technology and ensuring patient safety, this position offers the opportunity to shape the future of implantable devices.

Drive Innovation in Implantable Device Biocompatibility

In this pivotal role, you will lead a team dedicated to ensuring the highest biocompatibility standards for innovative implantable devices. You will collaborate with cross-functional teams to design, implement, and evaluate biocompatibility testing strategies that support product development and regulatory submissions. The ideal candidate will possess a deep understanding of ISO 10993, toxicology, and materials science, and have experience in leading biocompatibility assessments for medical devices. If you are ready to drive the next generation of medical device safety and performance, this is your chance to make a significant impact.

Key Responsibilities of the Director of Biocompatibility – Implantable Devices

Biocompatibility Strategy Development: Lead the creation and implementation of biocompatibility strategies for implantable devices. Ensure alignment with regulatory requirements and industry standards, ensuring product safety and performance through comprehensive testing and analysis.

Biocompatibility Testing & Assessment: Oversee the development and execution of biocompatibility testing plans for medical devices. Conduct toxicological risk assessments, evaluate materials for compatibility, and ensure devices meet ISO 10993 standards to safeguard patient health.

Regulatory Compliance & Submissions: Manage biocompatibility-related regulatory submissions, including 510(k), PMA, and CE Mark processes. Ensure that all device biocompatibility testing and data align with the applicable regulatory requirements for market approval.

Collaboration with Cross-Functional Teams: Partner closely with product development, R&D, and quality assurance teams to integrate biocompatibility considerations early in the design and development phases. Provide expert guidance to ensure seamless integration of biocompatibility testing throughout the product lifecycle.

Risk Management & Safety Oversight: Lead risk assessments and safety evaluations for implantable devices, identifying potential hazards and mitigating risks through strategic testing and improvements. Ensure all biocompatibility aspects are addressed to minimize adverse effects.

Continuous Improvement & Innovation: Stay ahead of evolving industry standards and best practices in biocompatibility testing. Drive the adoption of new technologies, methodologies, and improvements that enhance the safety and efficacy of implantable devices.

Team Leadership & Development: Manage and mentor a team of biocompatibility professionals, fostering a collaborative and innovative environment. Ensure continuous development of the team’s technical expertise and keep them aligned with company objectives and compliance goals.

Documentation & Reporting: Ensure the timely preparation and review of comprehensive reports documenting biocompatibility test results, risk assessments, and regulatory submissions. Maintain detailed records for auditing and regulatory review.

Supplier & External Relations: Manage relationships with external testing labs and suppliers, ensuring that all biocompatibility testing services meet company standards and regulatory expectations. Oversee vendor performance and resolve any issues that may arise.

Cross-Departmental Collaboration & Communication: Communicate biocompatibility findings and updates to internal stakeholders, including senior leadership, R&D, and regulatory teams. Ensure biocompatibility considerations are incorporated into product development and commercialization strategies.

What the Client is Looking for in You

As the Director of Biocompatibility – Implantable Devices, the client seeks a highly skilled and innovative leader with expertise in biocompatibility testing and regulatory compliance within the medical device industry. You should be an experienced professional who thrives in a dynamic environment and is capable of ensuring the safety and effectiveness of implantable devices while leading cross-functional teams to success.

Proven Expertise in Biocompatibility and Medical Device Safety

The client is looking for a biocompatibility expert with a strong background in implantable devices. You should have a solid track record of leading biocompatibility testing, toxicological risk assessments, and regulatory submissions. A deep understanding of ISO 10993 standards, toxicology, and the medical device lifecycle is essential for this role. The client values professionals who can ensure that all implantable devices meet the highest safety and regulatory standards.

Strategic Thinker with a Focus on Safety and Compliance

As the Director of Biocompatibility, you must demonstrate the ability to develop and execute strategies that ensure biocompatibility testing aligns with regulatory requirements and product development timelines. The ideal candidate will have experience anticipating challenges in biocompatibility and taking proactive steps to mitigate risks. A strong ability to collaborate with product development and R&D teams to integrate biocompatibility into the product design process is highly valued.

Strong Regulatory Knowledge and Compliance Focus

The client seeks a leader who is well-versed in medical device regulations, including FDA requirements, CE Marking, and other global standards. You should have experience in managing regulatory submissions for biocompatibility data, and the ability to navigate complex regulatory environments is essential. Your expertise in ensuring that all implantable devices comply with industry standards and mitigate potential risks will be critical to the company’s success.

Ability to Lead and Collaborate with Cross-Functional Teams

Leadership and collaboration are key in this role. The client is looking for a director who can lead a biocompatibility team while working closely with cross-functional teams, including R&D, product development, and regulatory affairs. You should be able to guide and mentor team members while fostering an environment of collaboration, continuous learning, and innovation.

Strong Analytical and Problem-Solving Skills

The client values a director who is detail-oriented and has strong analytical skills. You should be adept at assessing and interpreting data from biocompatibility tests, making informed decisions, and communicating findings clearly to stakeholders. Your ability to identify and resolve complex issues related to implantable device safety and performance will be critical.

Commitment to Innovation and Continuous Improvement

Finally, the client seeks a leader who is passionate about advancing medical technology. You should demonstrate a commitment to staying up-to-date with the latest developments in biocompatibility testing and regulatory changes. The ability to drive innovation and continuous improvement within the biocompatibility function will be crucial to the company’s growth and success in the implantable device market.

FAQs About the Role – Director of Biocompatibility – Implantable Devices

What are the key responsibilities of the Director of Biocompatibility in this role?
As the Director of Biocompatibility, you will oversee biocompatibility testing, ensuring that implantable devices meet regulatory and safety standards. You will manage biocompatibility risk assessments, lead the testing process, and ensure compliance with industry regulations like ISO 10993. Additionally, you will collaborate with cross-functional teams, oversee regulatory submissions, and guide product development to ensure safety and effectiveness throughout the lifecycle of the devices.
What qualifications and experience are required for this position?
The ideal candidate should have significant experience in biocompatibility testing, toxicology, and regulatory compliance in the medical device industry. A strong background in materials science, ISO 10993, and biocompatibility testing methodologies is essential. A degree in biomedical engineering, toxicology, or a related field is required, with advanced certifications or a master’s degree being a plus. Experience in implantable device biocompatibility and regulatory submissions will be highly valued.
What leadership qualities are essential for this role?
The client is seeking a leader with strong analytical skills, a deep understanding of biocompatibility testing, and the ability to drive strategic decision-making. You should have excellent communication skills to effectively collaborate with cross-functional teams and stakeholders. Being proactive, detail-oriented, and capable of leading teams through complex regulatory and safety challenges will be key to your success in this role.
What challenges can I expect in this role?
In this role, you will face challenges such as ensuring biocompatibility testing meets evolving regulatory requirements, managing risks associated with new implantable devices, and maintaining safety standards while driving product innovation. You will also navigate the complexity of global regulatory environments and ensure that all testing aligns with international standards. Additionally, managing tight timelines for product development and regulatory approval will be an ongoing challenge.
What is the expected impact of the Director of Biocompatibility on the company’s success?
The Director of Biocompatibility will play a crucial role in ensuring that implantable devices are safe for use, compliant with regulations, and ready for market approval. Your leadership in biocompatibility testing will directly impact the company’s ability to bring safe, high-quality products to market, enhancing the company’s reputation and positioning it as a leader in the implantable device industry.
What is the company’s culture and work environment like?
The company fosters an innovative, collaborative, and safety-focused work environment. They prioritize the well-being of patients and are committed to delivering high-quality medical devices. You will be working in a team-oriented atmosphere where your expertise in biocompatibility testing will be valued, and your input will be essential in ensuring the company’s success in the medical device market.

What Remuneration Can You Expect from This Job?

As the Director of Biocompatibility – Implantable Devices, you can expect a highly competitive and comprehensive compensation package. The remuneration for this role is designed to attract top-tier professionals with extensive experience in the medical device industry. The compensation package typically includes the following components:

Base Salary
The base salary for the Director of Biocompatibility role will vary depending on your experience, qualifications, and the company’s size and market position. For this role, base salaries generally range between $150,000 and $250,000 annually. However, larger organizations or those with more complex product lines may offer higher salaries based on individual expertise and the company’s needs.
Performance-Based Bonuses
In addition to the base salary, the compensation package may include annual performance-based bonuses. These bonuses are typically tied to key objectives such as successful regulatory approvals, risk mitigation, biocompatibility testing milestones, and overall device safety. Bonus percentages can range from 20% to 40% of the base salary, depending on individual and company performance.
Equity & Stock Options
Many companies in the medical device sector offer equity incentives to senior leaders, including stock options or restricted stock units (RSUs). These long-term incentives are designed to align your interests with the company’s performance and growth, offering potential financial rewards through company growth or an IPO. Depending on the company, equity grants can form a significant part of your total compensation package.
Profit-Sharing & Long-Term Incentive Plans (LTIPs)
Some companies offer long-term incentive plans (LTIPs) or profit-sharing opportunities to executives, rewarding consistent performance over multiple years. These incentives help ensure that leadership remains focused on the company’s long-term success, offering additional financial rewards based on achieving long-term growth and sustainability.
Executive Benefits & Perks
As a senior leader, you can expect a comprehensive executive benefits package, which may include:
- Health, dental, and vision insurance
- 401(k) or pension plans with company contributions
- Executive retirement plans
- Company-provided vehicle or travel allowances
- Executive wellness programs
- Expense accounts for business development, networking, and conferences
Signing Bonuses & Relocation Assistance
For candidates with highly sought-after expertise, companies may offer signing bonuses or relocation packages to attract top talent. These one-time incentives can range from $20,000 to $100,000, depending on the company and the candidate’s experience.

Total Compensation Potential

When factoring in base salary, bonuses, equity incentives, profit-sharing, and additional benefits, the total compensation for a Director of Biocompatibility – Implantable Devices can range from $200,000 to $400,000 annually. In larger or high-growth companies, the total compensation could exceed these amounts, with lucrative bonus structures and stock options adding to the overall package.

How to Apply

If you are a seasoned expert in biocompatibility testing with a strong background in the medical device industry, we encourage you to apply for the Director of Biocompatibility – Implantable Devices role in Tampa, FL. This is a significant opportunity to lead biocompatibility strategies for cutting-edge implantable devices, ensuring the safety and regulatory compliance of life-saving products.

To apply, please submit your resume along with a cover letter that highlights your experience in biocompatibility, regulatory compliance, and toxicology, especially in the context of implantable devices. Be sure to detail your accomplishments in leading biocompatibility assessments, your familiarity with regulatory standards (such as ISO 10993), and your ability to work with cross-functional teams to ensure product safety.

This is an impactful role where your expertise will directly contribute to the success of innovative implantable devices that improve patient lives. Apply today to advance your career as a Director of Biocompatibility in the rapidly evolving medical device sector!

For more information or to explore similar opportunities, visit our Biocompatibility Careers Page.

Job Category: Implantable Devices

Job Type: Full Time

Job Location: Tampa

Director of Biocompatibility – Tampa, FL | Implantable Devices