Sr. Director of Regulatory

Sr. Director of Regulatory

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Director/Sr. Director, Regulatory Affairs
At Dascena, our mission is to develop and implement clinically proven machine learning algorithms to improve patient outcomes. Our innovations help detect disease, improve the delivery of care, and saves lives. In this role, you will be responsible for Dascena’s regulatory success. The role spans product and regulatory strategy, ownership of the relationship with the FDA and other regulatory agencies, and mission critical guidance and collaboration with cross-functional teams to build, submit, and see through agency approval. The role also includes building strong relationships with our clinical and strategic partners to assure continued compliance with FDA, ISO and other regulatory standards.

What you’ll do:

• Manage regulatory oversight, including leading all communications and submissions with regulatory agencies, continuing for the entire product development life cycle, including post-market surveillance.
• Develop strategy and execute plan for ISO 13485 certification.
• Own regulatory timelines and management of regulatory submissions and compliance for our Software as a Medical Device (SaMD) solutions. Future regulatory submissions may include expansion of claims to existing products where regulatory submission is based off of real-world evidence data submissions; be prepared to navigate such ambitions in collaboration with clinical affairs leaders.
• Own execution of sound SaMD and clinical decision support (CDS) health regulatory strategy for the company's medical devices involving use of SaMD, Artificial Intelligence, and Machine Learning to achieve clearances/approvals in alignment with business priorities.
• Maintain a strong grasp of regulatory guidance and trends, ensuring that information is disseminated across the organization for effective decision making; may involve executive education to ensure senior leaders in Dascena have a good understanding of the regulatory landscape.
• Guide leadership in deciding when algorithm use cases on the product roadmap should undergo a SaMD path versus a non-regulated clinical decision support (CDS) pathway.
• Develop and design robust regulatory structures, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy to support research, clinical trials, algorithm and product development and commercialization efforts.
• Serve as primary regulatory agency representative in interactions with the FDA and other regulatory agencies to achieve company regulatory objectives by fostering strong relationships and acting as a credible, reputable, ethical and effective advocate for Dascena.
• Provide leadership and oversight for all regulatory submissions, regulatory compliance (e.g. ISO 13485, 21 CFR 820), regulatory advice and counseling in all areas of development and commercial regulatory activities across the lifecycle of products.
• Ensure quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs. Creates and implements new SOPs as necessary to maintain regulatory compliance.
• Manage timely reporting of clinical trial issues to regulatory authorities and the generation of clinical study reports.
• Provide regulatory review and approval of product labeling, promotional claims and advertising to ensure compliance with corporate policy and applicable regulatory requirements.
• Contribute to organizational change by creating and sustaining a work environment conducive to continuous improvement.
• Assess, develop and upgrade the capabilities of the Quality and Regulatory Affairs organization to meet evolving needs in the internal and external environment.
• Work closely with department heads to identify and quantify risk for the organization.
• Stay informed of new and revised regulations; disseminate information as directed by management.
• Develop and implement an organized filing system for all regulatory filings.
• Perform other job-related duties as assigned.

What you have:

• Bachelor’s degree in a biological science or technical/data science discipline, advanced degree strongly preferred.
• 10+ years of progressive Regulatory Affairs experience within the medical device industry with demonstrated leadership and/or management experience.
• Demonstrated experience:
• Sound knowledge of SaMD US FDA digital health regulations and requirements, legislation, industry standards and guidance.
• Successful management of the regulatory and compliance process in a complex product development context.
• Leading, designing, writing, and submitting regulatory filings and correspondence and/or approvals is required.
• Supporting commercialization and post-marketing activities and requirements for approved products in the US.
• Influencing, gaining consensus, and overcoming resistance by presenting a powerful case for implementing new initiatives or ideas.
• As a subject matter expert in pre- and post-market medical device regulations, requirements and submissions, especially De Novo submissions, PMA, 510(k), and 21CFR820.30.
• Familiarity with ISO 62304 and IEC/ISO 62304 medical device software life cycle process also desired.
• Excellent scientific written and oral communication skills with an ability to communicate complex medical/clinical concepts to both internal and external stakeholders.

What you’ll bring:

• Proven track record of introducing processes and improving efficiencies while managing all aspects of the company's quality management and regulatory compliance to support the continuous growth and expansion of an organization.
• Thought leadership in the regulatory field and a track record being able to develop and manage relationships with key opinion leaders.
• Ability to create and communicate a clear vision among team members effectively aligning resources to achieve functional area goals and inspiring strategic thinking to problem-solve.
• The ability to establish credibility, trust and strong working relationships both inside and outside the organization.
• The ability to run a high-quality Regulatory team that can develop and execute on multiple projects simultaneously.

Other Information:

• To perform this job successfully, the successful candidate must be able to perform each essential duty satisfactorily. Reasonable accommodations will be made to enable qualified individuals with disabilities to perform the essential functions.
• To continue to expand our diverse workforce, Dascena encourages applications from individuals with disabilities, minorities, veterans, and women. Dascena is an equal opportunity employer. All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, disability, veteran status, or any other basis protected by applicable federal, state, or local law.