As Resolve Stroke continues to grow, with increasing demand from clinical partners and key regulatory milestones ahead, we are seeking an experienced Clinical Affairs Specialist with strong expertise in regulatory affairs, and experience interacting with the FDA and Notified Bodies.

In this role, you will lead the clinical development strategy for our ultrasound-based diagnostic technologies. You will collaborate closely with cross-functional teams, including clinical operations, regulatory affairs, and product development to ensure our solutions meet regulatory standards and succeed in the market.

Responsabilities:

1. Clinical strategy

   • Interact with Key Opinion Leaders to gain deeper insights into clinical needs.

   • Identify relevant use cases and their strategic importance.

   • Develop and implement clinical trial strategies and protocols aligned with organizational objectives.

2. Clinical Evaluation

   • Lead the clinical evaluation process of our products and write the clinical evaluation documents in line with the regulatory requirements in Europe and the USA.

   • Manage all aspects of clinical investigations, including study design, protocol writing, site selection, regulatory supervision, etc… to complete the clinical evaluation when needed.

   • Be responsible for CEP/CER, post market surveillance and vigilance obligations.

   • Collaborate with cross-functional teams and investigators to ensure the successful execution of clinical investigations, including project management, planning and budgeting.

   • Work closely with clinicians and investigational sites to ensure high-quality data collection and meaningful clinical outputs.

   • Stay current with clinical research methodologies, industry trends, and evolving regulatory guidelines.

3. Team Leadership and Collaboration

   • Provide strategic guidance and leadership to the clinical and regulatory affairs team.

   • Foster a collaborative and results-oriented environment, promoting cross-functional collaboration and knowledge sharing.

   • Mentor and develop team members, promoting their professional growth and ensuring their expertise aligns with company objectives.

What we offer:

• A unique opportunity to join a fast-growing HealthTech startup at the forefront of innovation in medical imaging.

• The chance to contribute to a high-impact clinical project with the potential to transform patient care.

• A respectful, collaborative, and dynamic work environment that values initiative and creativity—while keeping things fun.

• Full ownership of your role, with significant autonomy and the ability to shape both strategy and execution.

We look for:

• Master’s degree in a relevant field (e.g. life sciences, biomedical engineering, or health sciences).

• Minimum of 4 years’ experience in a clinical leadership role within a private company, preferably with medical devices.

• Proven experience with FDA and Notified Bodies regulatory submissions.

• Proven experience managing clinical trial, including design and execution.

• Knowledge of applicable regulations and standards, such as MDR 2017/745 and ISO 13485.

Who you are:

• Fluent in spoken and written English. Knowledge of French is a plus

• Ability to work effectively in a fast-paced and dynamic start-up environment

• Strong autonomy, analytical, organizational, and problem-solving skills,

• A committed, enthusiastic person with a “can-do”, creative mindset

• Previous experience and/or a strong interest in developing healthcare products

• Cultivating open communication and a culture of constant feedback

• A natural leader, capable of driving a team, eager to learn and help your team progress

What we value:

We value a positive mindset, sense of ownership, scientific integrity, attention to details, excellence, ambition, the ability to embrace ambiguity, a talk-less-do-more attitude, and a sense of humor to enjoy ourselves along the way. If you identify with our values and want to contribute to our company, we’d love to have you in!

1. Introductory phone call.

2. Performance interview in our office or by Zoom.

3. Culture interview with the CTO or CEO.

4. In the end, we’ll do some reference calls.