Sr./Director, Regulatory Affairs

As a Sr. Director of Regulatory Affairs at Cleerly, your primary responsibilities will include overseeing regulatory submissions and approvals, developing regulatory strategies for product advancement, and ensuring compliance with industry regulations. You'll lead cross-functional collaborations with R&D and clinical teams and conduct risk management processes to align our innovative heart diagnostic solutions with regulatory requirements.

To be considered for the Sr. Director of Regulatory Affairs at Cleerly, you’ll need at least 15 years of regulatory affairs management experience, preferably in AI and SaMD (Software as a Medical Device). A bachelor’s degree in life sciences or engineering is required, and an advanced degree is preferred. Familiarity with FDA regulations, ISO standards, and medical device requirements is essential, along with strong leadership and communication skills.

Cleerly ensures compliance in its regulatory affairs processes by implementing robust risk management strategies, developing comprehensive regulatory plans, and establishing quality policies. The Sr. Director of Regulatory Affairs plays a crucial role in conducting audits, supporting internal and external reviews, and staying updated with changing regulations to maintain high standards for our heart care products.

As a Sr. Director of Regulatory Affairs at Cleerly, you can expect a collaborative, innovative, and remote-friendly work environment. Our team values digital collaboration using tools like Google Workspace and Slack, allowing you to work closely with engineers, clinicians, and data scientists to create effective regulatory strategies while contributing to meaningful advancements in heart care.

Cleerly emphasizes continuous growth and professional development. As a Sr. Director of Regulatory Affairs, you’ll have opportunities to take on new challenges, broaden your expertise in regulatory practices for medical devices, and contribute to industry-leading projects. We encourage a culture of learning, providing access to resources and support for your career advancement.

When answering, consider sharing specific instances where you managed FDA submissions, focusing on successful outcomes. Highlight your familiarity with 510(k), de novo requests, and any challenges you faced. Discuss how your regulatory strategies positively impacted the submission process.

Share insights on your approach to regulatory intelligence, such as following industry publications, attending workshops, and participating in professional associations. Emphasize the importance of these activities in ensuring compliance and adapting quickly to regulatory shifts.

Discuss your collaboration techniques with teams from R&D, clinical, and product development. Highlight methods for ensuring all stakeholders understand and integrate regulatory requirements, which enhances overall project efficacy and compliance.

Provide a detailed explanation of your process for identifying, assessing, and mitigating risks in product development. Highlight specific methodologies or frameworks you utilize, such as ISO 14971, to demonstrate your expertise.

Think of a specific audit or inspection where you were instrumental. Discuss your preparation process, how you communicated with teams, and any corrective actions taken to meet compliance successfully. This will showcase your leadership and problem-solving skills.

Emphasize key elements such as data integrity, risk assessment, and documentation quality in your response. Discuss the significance of aligning submission strategies with regulatory expectations and potential pitfalls to avoid.

Describe techniques you use to simplify regulatory concepts for diverse audiences. Sharing examples where you successfully conveyed important information to marketing or sales teams can illustrate your communication prowess.

Comment on the evolving nature of regulations surrounding cutting-edge technologies like AI in healthcare. Discuss challenges like ensuring safety and efficacy, compliance with rapidly changing regulations, and the balance between innovation and regulation.

Convey your methodology for assessing product changes and their regulatory implications. Discuss factors you consider in evaluating risk and compliance, and showcase your problem-solving abilities in navigating these situations.

Share your insights on post-market surveillance strategies, highlighting your role in monitoring product performance after market entry. Discuss your methods for evaluating risks and ensuring ongoing compliance as per regulatory requirements.