Sr. Regulatory Affairs Specialist

Empatica is a full-stack, digital healthcare company, revolutionizing health monitoring and treatment development through our AI platform, digital biomarkers, and advanced medical wearables. Our clients include leading institutions like NASA, Harvard University, and top pharmaceutical companies, as well as individual users whose lives have been transformed by our products.

If you seek to join a fast-paced, growth-oriented environment and make a meaningful impact, keep reading.

About the role

We are seeking a Regulatory Affairs Manager to join our Quality and Regulatory Department. You will oversee regulatory activities, including pre-market submissions to the FDA and technical documentation for CE certification under EU Medical Device Regulation 2017/745.

Your responsibilities will include developing Empatica’s product registration strategies, assessing new and revised regulatory requirements, and proposing implementation plans. Collaborating with the product management team, you will help guide the company towards improving health outcomes globally by building innovative products and processes.

Key responsibilities:

1. Define product regulatory strategies and roadmaps, prioritizing requirements and coordinating with scientists, engineers, and management.
2. Collaborate with data science teams to validate algorithms and biomarkers, ensuring regulatory compliance in an agile development environment.
3. Represent regulatory affairs in cross-functional teams during product development and commercialization.
4. Develop and maintain regulatory SOPs.
5. Prepare and manage regulatory documentation such as Q-Sub, 510(k), DeNovo submissions, and technical files for CE marking.
6. Gather and evaluate clinical trial data.
7. Assess proposed changes to approved products for regulatory impact and gather data to support regulatory strategies.
8. Provide regulatory risk assessments and intelligence regarding Empatica devices.
9. Review technical reports and change controls for compliance and adequacy.
10. Communicate regulatory requirements across the organization.
11. Train staff on regulatory topics.

Requirements:

• Native or proficient English speaker (minimum C1 level).
• BSc or MSc in Biomedical Engineering or related field.
• At least 5 years of experience in regulatory affairs within medical device, wearable, or IoT device companies.
• Strong analytical, problem-solving, and project management skills.
• Knowledge of ISO standards, EU MDR 2017/745, and FDA 510(k) processes.
• Experience with clinical evaluation activities.

Life at Empatica

Join our diverse, international team of over 90 passionate professionals dedicated to making a difference. Collaborate across all levels, learn from industry pioneers, and take ownership of impactful projects that help thousands worldwide.

While challenging, this opportunity offers rewarding growth, skill development, and meaningful contribution. Discover why our team loves working at Empatica by reading our blog.

Inclusion & Diversity

We celebrate diversity, with colleagues from 21 countries and 50% women in our team. We believe diverse perspectives foster innovation, collaboration, and a supportive workplace.

Benefits

• Challenging opportunities in a rapidly growing company at the forefront of technology.
• Competitive salary and employee stock options.
• Offices in Milan City Center and Downtown Boston.