Asensus Surgical is currently seeking a QA/RA Specialist to join our team in Milan for a fixed-term period.
You'll be responsible for supporting production and process quality and regulatory pre- and post-market objectives for Asensus medical device marketing. You will also support PMS efforts of the European Regulatory Affairs and QMS team as well as the development and maintenance of Technical Documentation for MDR CE Certification and international product registrations (EMEA/CIS).
Who We Are
As a medical device company, Asensus is digitizing surgery to pioneer a new era of Performance-Guided Surgery. Utilizing robotic technology to improve minimally invasive surgery in ways that matter to patients, physicians, surgical staff, and hospitals and enabling consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus Surgical looking for a fulfilling career, and that's exactly what they find.
Want more jobs like this?
Get jobs in Milan, Italy delivered to your inbox every week.
What You Bring
- A minimum of a Bachelor's Degree in engineering or scientific discipline is required.
- A minimum of 2 years of medical device Regulatory Affairs and/or Quality Assurance experience is required.
- Knowledge of ISO 13485 and 2017/745 MDR is required.
- Knowledge of 21 CFR Part 820 and ISO 14971 preferred.
- Experience with Technical Documentation (MDR) management is preferred.
- Experience with international product registrations is preferred.
- Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing.
- Ability to work as a member of a team in a timeline-driven environment.
- Full professional proficiency in English and Italian (verbal, written, listening).
What You'll Do
- Support the management of Technical Documentation for product change and the preparation of Technical Documentation for new product development.
- Support the update of PMS/PMCF deliverables for MDR CE purpose.
- Perform assessments of complaints for Medical Device Vigilance reporting responsibility of manufacturer.
- Maintain the IMoH and EUDAMED databases as applicable and supports international product registrations (EMEA/CIS).
- Keeps current in regard to international medical device regulations, guidance documents.
- Support complaints management: contributes to product complaints investigations; works on complaints metrics.
- Support management of quality metrics, dashboards and KPIs.
- Perform product releases as applicable.
- Support suppliers monitoring.
- Ensure compliance with local Asensus quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
What We Offer
- A culture driven to achieve our mission and deliver remarkable results
- Coworkers committed to collaboration and winning the right way
- Quality products that improve the lives of our customers and patients
- Ability to discover your strengths, follow your passion and find your own rewarding career
At Asensus Surgical, we believe in contributing to a society that welcomes diverse voices and values differences in lived experiences, culture, religion, age, gender identity, sexual orientation, race, ethnicity, and neurodiversity. We are committed to ensuring this same environment for our employees - a culture where individuals feel safe, heard, and respected. We celebrate the uniqueness of our global workforce and know that only through inclusion, ongoing learning, and partnership can we succeed. Together we are all stronger.