Quality & Regulatory Affairs Specialist (M/F) Bardi

Quality & Regulatory Affairs Specialist (M/F)
Bardi
Emilia Romagna, Bardi

Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients. Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation. Our seasoned leadership and dedicated global team of more than 2, 500 is focused on shaping an exciting future for ZimVie — we hope you'll consider being a part of it!_

**Job Mission**:

Based in our Cantù (CO) office, we are looking for a Quality & Regulatory Specialist, joining our EMEA team.

Perform duties in maintaining regulatory compliance for products marketed within the EU, FDA and MEA Countries with primary emphasis on communications to the Competent Authorities.

Support the Legal Manufacturer Activities through the maintenance and continuous improvement of the QMS according to EU MDR, FDA and ISO 13485:2016.

**Principal Duties and Responsibilities**:

- Ensure that Quality Management System is successfully maintained and improved when needed and support RA activities.

- Support maintenance, update and creation of TDs and 510(K) for Class I, and IIa surgical instruments, collaborating in the registration submissions with the EMEA team.

- Support in the Reporting and management of metrics (KPIs) at required meetings (e. g. CAPA Trigger, Management Review, complaints, NCs, calibration).

- Notify the Competent Authorities of any changes when needed according to instructions of EMEA HQ.

- Participation in internal and external audits and any responses to cited issues being the ownership of corrective actions stemming from these audits.

- Ensure compliance with local and European medical device regulations, registrations and reporting requirements.

**Education/Experience Requirements**:

- University degree in scientific or engineering discipline.

- At least 3-year experience in medical device regulatory and quality.

- Demonstrated experience in handling requirements of ISO 13485:2016 and EU MDR

- Ability to interface with the different departments of the organization.

- Good time management skills, able to work effectively in a demanding environment.

- Perform multiple tasks concurrently with accuracy.

- Well-developed analytical skills and ability to pay particular attention to details.

- Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, etc)

- Fluent in English & Italian. Other European languages, as Spanish is a plus.

**Our offer**:

ZimVie offers you a challenging position with good career prospects in a fast-growing international business. We offer a competitive remuneration package.

- Permanent contract

- Competitive fixed salary

- Meal voucher

- Partially remote work option available

- International working environment

- ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity. _