Director of Regulatory Affairs

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company below:

The Director of Regulatory Affairs (RA) is a functional leader of Cresilon. The Director of RA oversees the following functions: Regulatory Strategy, Regulatory Operations, and Regulatory Intelligence. The Director of RA is responsible for developing and executing Cresilon’s regulatory strategies across the life-cycle of Cresilon’s products. The RA Director is well versed in US, EU, and international medical device regulations and develops the least-burdensome commercialization approaches within a highly cross-functional environment. The RA Director adopts and maintains a culture of excellence and quality in all aspects of their job function. The RA Director works in a highly-regulated environment and aids in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Cresilon.

Responsibilities:

Lead the creation and execution of proactive regulatory strategies for product development, approval, and commercialization.

Ensure all regulatory strategies have cross-functional buy-in, are fluid, and robust, as appropriate.

Monitor, interpret, and communicate changes in regulatory requirements to internal teams. Ensure that all products and processes comply with relevant regulations and guidelines.

Serve as the primary point of contact for interactions with regulatory agencies and authorities.

Prepare and submit regulatory submissions, including new applications, product registrations, and other required documentation.

Collaborate with Quality teams to ensure compliance with regulatory standards, including but not limited to GMP, GLP, and GCP, as applicable.

Lead regulatory submission deliverables.

Foster strong relationships with regulatory agencies, representing the company during regulatory inspections, meetings, and inquiries, as appropriate.

Collaborate with the Quality team to establish and maintain a culture of quality and compliance within the organization.

Oversee the creation, maintenance, and organization of regulatory documentation.

Lead and mentor a team of regulatory affairs professionals, fostering their growth and development.

Stay informed about evolving regulatory trends and changes, providing insights and recommendations to the executive team.

Act as Official Correspondent to Regulatory Authorities (e.g., FDA) on behalf of Cresilon, Inc.

Submit Marketing Applications to Regulatory Authorities on behalf of Cresilon, Inc.

Represent Cresilon, Inc to Regulatory Authorities, both in writing and in person.

Requirements

Education

Bachelor’s degree in science, engineering, or related life-science discipline (master's degree in chemical engineering, Biomedical Engineering, Material Science, or Regulatory Affairs preferred)

RAC or Equivalent Certificate Preferred

Experience

8 years in overall USA medical device regulatory affairs (10 years preferred)

5 years in overall EU medical device regulatory affairs (8 preferred)

5 years of therapeutic medical device experience (NOT diagnostics nor instrumentation)

2 years of management in medical device / pharmaceutical quality (4 years preferred)

2 USA medical device marketing applications for Class II or III medical devices (e.g., 510(k), PMA) where you are listed as the Official Correspondent (5 preferred)

1 USA Q-Submission Meeting where you were listed as the Official Correspondent (3 preferred)

1 EU medical device marketing application for Class IIa, IIb, or III medical devices (i.e., CE-marking) where you are listed as the Official Correspondent (3 preferred)

International medical device processes

Biocompatibility Requirements per ISO 10993, FDA Guidance, and MDR Requirements

Risk-assessments, including but not limited to D-FMEAs, P-FMEAs, Biocompatibility Risk Assessments (BRA), and Toxicological Risk Assessments (TRA)

Risk management per ISO 14971

Technical problem-solving using science and engineering principles

Analytical chemistry and physical characterization methods to support Marketing Applications

Microbiology methods to support Marketing Applications

US Medical Device Reporting (MDR) per 21 CFR § 803

Post Market Surveillance Requirements

Preferred Qualifications

Expertise in US Medical Device Regulatory Processes (i.e., 510(k), De Novo, Pre-Market Approvals (PMAs), etc.)

Expertise in EU Medical Device Regulatory Processes (i.e., CE Marking, Conformity Assessments, Technical Files Development)

Technical Writing for Regulatory Authority Correspondence

Ability to Develop People – Coaches people in their current roles to improve performance and prepares them for future roles.

Emotional Intelligence – Self-aware and aware of others. Navigates relationships with empathy.

Efficiency & Organization – Plans, organizes, schedules, and budgets precisely with keen attention to detail. Focuses on key priorities. Produces significant output with minimal wasted effort.

Honesty & Integrity – Does not cut corners ethically. Earns trust and maintains confidences. Does what is right, not just what is politically expedient. Speaks plainly and truthfully while maintaining professionalism.

Strategic Planning & Organizational Development – Determines opportunities and threats through intuition and trend analysis. Implements recommendations accordingly.

Proactivity – Acts without being told what to do. Brings new ideas to the company.

Quality Management System Requirements per 21 CFR § 820 and ISO 13485

Drug and biologics regulatory processes

Microsoft Office suite

Electronic signature platforms (e.g., Adobe Sign, DocuSign)

Pharmaceutical / medical device quality operations and manufacturing

Benefits

Paid Vacation, Sick, & Holidays

Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Company Paid Life and Short-Term Disability Coverage

Work/Life Employee Assistance Program

401(k) & Roth Retirement Savings Plan with company match up to 5%

Monthly MetroCard Reimbursement

Salary Range: $160,000-$220,000