We are looking for a Regulatory Affairs Specialist with amazing skills to understand internal engineering workflows and properly document them for both internal and external stakeholders. You will be part of the team responsible for the development of both medical and company certifications, as well as supporting management in the optimization of internal workflows. You posses great organizational skills and are able to implement and improve procedures for Empatica products according to the regulatory requirements.
You are a passionate specialist with a broad knowledge in the pharmaceutical/medical device industry. At Empatica you will be able express your potential. We need people that can take decisions and achieve results with independence. In addition we need creative people that are able to find solutions that could be more efficient in terms of time or resources.
You will join an elite team of hard-working and passionate people and will be involved in:
- Create new and keep the current document knowledge base updated.
- Continuously monitor changes in the internal teams workflow and make sure that they are compliant with regulations.
- Prepare documentation for audits.
- Plan and prepare and review documentation for FDA, according to overall company strategy.
- Collaborate and network with numerous internal teams including Management, Ops, Business development, Hardware, Data, Software development, and Firmware development.
- Verify and document that internal workflows and procedures are compliant with ISO/IEC standards.
As the ideal candidate for this position you:
- Have a genuine interest, passion and motivation for Empaticas mission.
- Have a strong academic background, BS or MS in Computer Science or Electrical Engineering is a plus
- Have at least 3 years experience as a Document Control Specialist or Technical writer in a company that designs/manufactures medical devices, wearable devices or IoT devices.
- Have strong knowledge and experience working with ISO standards (13485, 14971, ...).
- Have strong knowledge and experience working with IEC standards (60601, 62304, ...).
- Have strong knowledge and experience working with FDA 510(k) clearance process.
- Have excellent analytical and problem-solving skills.
- Are an autonomous person, with good organization and management skills.
- Are a native English speaker or have worked in English for the past at least 3 years.
The ideal candidate for Empatica:
- Is a reliable and effective worker; working in a fast growing startup is not for everyone.
- Is creative, fun and easy to work with.
- Is self-motivated, with good leadership skills.
- Is a critical thinker and always questions dogma, status quo, and the conventional way of doing things.
- Is able to manage a variety of assignments.
- Is detail oriented and highly organized.
We expect a lot from you, but your efforts will be rewarded by great benefits:
- Competitive salary
- The position could be filled in our Milan HQ or Boston HQ. Plus we have an amazing beach summer office in Sardinia, Italy!
- MacBook Pro
- Flexible work hours
- Free cookies, if you deserve them
- Much more...