In InnovHeart we aim to bring patients a novel therapeutic system suitable to replace incompetent Mitral Valves based on a safe, effective, and easy-to-use transcatheter technology.
We are about to start clinical trial with our Saturn transeptal procedure and we are now looking for a responsible for Regulatory Affairs activities to lead regulatory submissions, registrations, listings and annual reports.
Ensure compliance with applicable medical device regulations per jurisdiction, guidance and standards.
Creation and maintenance of regulatory files.
This position will be reporting to the VP Clinical & Regulatory, based in the US.
Remote work is allowed with the possibility to visit our Italian site in Colleretto Giacosa (TO) on a regular basis.
**Responsibilities**
- Stay abreast of regulatory requirements, procedures and latest changes in regulatory climate to allow a thorough gathering of the applicable regulatory requirements and input to the QMS and the design and development Team.
- Review and support the design and development activities e.g.
the preparation of product labeling including instruction for use and training material for compliance with applicable regulations and technical standards.
- Write, edit and analyze technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Europe and China through the local legal agent.
Work with other departments and communicate the submission requirements when documents are needed for regulatory submissions.
- Maintain regulatory files.
Maintain and update regulatory authorizations, such as IDEs, submissions and follow-up with National Competent Authorities (NCAs) in Europe and support the establishment and maintenance of the Medical Device Technical documentation in view of the conformity assessment or approval in different geographies.
- Prepare responses to regulatory authority questions within assigned timelines.
- Support the assessment of device deficiencies of investigational devices employed in clinical investigations.
Compile and submit reportable events to relevant regulatory authorities in timely manner.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Other duties as assigned
**Qualifications**
- 3-5 years of previous medical device regulatory affairs experience required
- Minimum of 1 year experience working at a structural heart company a plus
- Bachelor's degree in Engineering or Science or related scientific discipline.
Higher degree/PhD a plus.
- Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
- English language excellent written and verbal communication skills with the ability to listen, articulate and advocate
- Proactive, high performance, result oriented and ability to manage multiple projects and deadlines
- Technical system skills (e.g.
databases, efficient online research)
- Ability to identify compliance risks and escalate when necessary
- Demonstrate both creative and critical thinking skills.
**Job Types**: Full-time, Permanent
**Salary**: €50,000.00 - €85,000.00 per year