Sr. Regulatory Affairs Specialist
Empatica, Italy
Job Description
If you are looking to join a fast-paced growth environment and do meaningful work that can make a true impact in the world, then keep reading.
You will be responsible for drafting Empatica’s product registration strategy, evaluating new and revised applicable regulatory requirements, and proposing possible implementation strategies.
Eventually, together with the rest of the product management team in Empatica, you will help steer the company towards the vision of unlocking better health outcomes for thousands of people. You will build amazing products and processes that will deliver outsized value to our customers and society.
You will be involved in:
- Setting the product regulatory strategy and roadmap by prioritizing regulatory requirements, building consensus, and coordinating deliverables with scientists, engineers, and management.
- Interacting with the data science team to validate new algorithms, and biomarkers, and making sure our development process is agile but regulatory friendly. You will drive and uphold rigorous regulatory standards, bringing consistency to the analyses you encounter and ensuring our discoveries are adequately reviewed.
- Serving as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization.
- Creation and maintenance of Regulatory related SOPs
- Creation of Q-Sub, 510K (or DeNovo) documentation
- Creation of Technical Documentation for CE marking
- Collection of Clinical trial results
- Contacting FDA and other Regulatory authorities to review status updates for pending applications and supplements
- Evaluating proposed changes to approved products for potential Regulatory impact and gathering required data as needed to defend a Regulatory filing strategy
- Providing regulatory risk assessments and intelligence on Empatica devices
- Reviewing technical reports, summary documents, and change controls for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
- Communicating regulatory requirements and expectations across the company.
- Training employees on regulatory aspects
Requirements
As the ideal candidate for this position you:
- Are a native English speaker or proficient in English (minimum C1)
- Have a strong academic background, BS or MS in Biomedical Engineering
- Have at least 5 years of experience as a Regulatory Affairs Specialist, preferably in a company that designs/manufactures medical devices, wearable devices or IoT devices
- Strong analytical and problem solving skills
- Have knowledge and experience working with ISO standards, EU MDR 2017/745 and FDA 510(k) clearance process
- Have experience in Clinical Evaluation activities
- Excellent project management skills
You will join a fast-growing, international, and diverse team of 90+ talented people who care passionately about what we do and the difference we are making in the world. You’ll get the opportunity to work directly with colleagues across all levels of the organization, no matter their seniority, and learn from the people that built the business and our products.
If you jump on board, we can guarantee it won't be an easy ride, but it will be one of the most rewarding experiences in your career, one that will allow you to learn a lot, have true ownership of your work, and test your whole skillset on multiple projects which are helping thousands of people worldwide.
Read our blog post and find out some reasons why we love working at Empatica.
Inclusion amp; Diversity
At Empatica we embrace diversity and inclusion. We have colleagues from 21 different countries, while 50% of our team is women (double the tech average!) We believe this makes Empatica a more exciting and stimulating place to work, and brings different points of view to the table while fost