Director of Regulatory Affairs

Contraline’s mission is to develop with novel male contraceptive technology. The company’s lead product is ADAM™, the world’s first implantable hydrogel designed to provide long-lasting, non-hormonal, and reversible contraception for men. Contraline further aims to use its

hydrogel platform technology to address global reproductive health challenges that have nosolutions and large unmet needs.

Summary

The Senior Manager / Director of Regulatory Affairs will be responsible for creating and executing the regulatory strategy for our lead product, an implantable male contraceptive device. This position requires strong regulatory knowledge and ability to manage premarket (PMA) and 510(k) submissions. This position reports to the Chief Technology Officer.

Primary Responsibilities

• Prepare regulatory submissions to FDA, Health Canada, EU Notified Bodies, and other regulatory agencies, with a focus on 510(k) and PMA submissions for Class II and Class III devices.
• Apply technical regulatory expertise to propose solutions on complex issues
• Interact and negotiate with regulatory authorities during submissions and provide timely and accurate feedback
• Ensure that submissions are of high quality, properly formatted, and comply with regulatory requirements
• Provide US regulatory intelligence, including interpretations of applicable or newly issued regulations and guidelines
• Represent regulatory function on Product Development teams
• Collaborate with Contraline departments (R&D, operations, quality, clinical affairs) to ensure studies and projects are executed to meet regulatory goals
• Review all nonclinical and clinical study protocols and provide feedback
• Effectively participate in Regulatory audits, including FDA and TGA, Health Canada and EU Notified Bodies

Applicants Should Meet The Following Criteria

• Bachelor’s degree in science, Engineering, or a related field
• Sr. Manager: 7-10 years of regulatory experience within the medical device Industry Director: 10+ years of regulatory experience within the medical device industry
• A proven track record of successful 510(k) and PMA submissions
• Experience with urological devices is desired, but not required
• Knowledge of EU MDR, FDA, and other global regulatory requirements
• Strong project management skills and experience with technical documentation
• Excellent communication, leadership, and organizational skills (detail-oriented)
• Self-starter attitude; desire to work in a fast-paced start-up company
• Ability to manage multiple projects simultaneously and adapt to new goals

What We Offer

• Full-time position at an exciting (pre-Series B) medical device company revolutionizing
• the contraception industry
• A competitive salary commensurate with the qualifications and experience of the
• candidate
• Starting date: as soon as possible
• Position can be based remotely or on-site in Charlottesville, Virginia. We encourage candidates who are open to relocating and will provide relocation assistance for those who choose to move to Charlottesville.
• Benefits: healthcare, dental, vision, 401(k), unlimited paid-time off (PTO), computer

Applicants must be authorized to work in the United States.

Contraline is a Charlottesville-based company working at the forefront of reproductive medicine. We believe that we go further when we go together. We are dedicated to building a diverse, inclusive and authentic workplace. If you”re excited about this role but your past experience doesn”t align perfectly with every qualification in the job description, we encourage you to apply anyways. All backgrounds, identities, and voices are welcomed!

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