Position

The candidate will be part of the Quality Assurance and Regulatory Affairs department and will primarily perform activities related to device registration with the FDA for access to the United States market. They will also need to interact proactively with all company departments.

The main activities are:

• Define and implement the regulatory strategy for medical device registration in the United States (FDA)
• Identify the appropriate regulatory pathway (e.g., 510K)
• Interface with the FDA for document submission and any requests
• Independently prepare, review, and submit regulatory dossiers (medical devices of all classes – III, IIb, IIa, I)
• Manage technical documentation according to FDA requirements
• Supervise risk management activities
• Coordinate the collection of necessary clinical and preclinical data by interfacing with the clinical office
• Manage establishment registration and device listing with the FDA
• Ensure compliance with quality management system requirements and prepare the company for FDA inspections
• Support internal and external audits
• Verify the company’s quality management system and update it if necessary to ensure compliance with specific requirements, ensuring alignment with the ISO 13485 standard
• Manage CAPAs, non-conformities, and change controls in collaboration with the involved company functions
• Monitor FDA regulatory updates
• Manage any post-market reports
• Provide support for device certification in accordance with the MDR 2017/745 regulation

Education and Experience

• Technical degree in chemical, mechanical or biomedical engineering, or other scientific disciplines.
• Excellent knowledge of spoken and written English.
• At least 5 years of previous experience in Quality Assurance within the medical device sector and experience in the management and registration of medical devices in the United States.

Skills and competencies:

Knowledge of the main standards and laws applicable to the medical device sector; specifically, knowledge of the following standards and regulations is mandatory:

• ISO 13485
• ISO 14971
• Directive 93/42/EEC
• Regulation (EU) 2017/745
• 510K procedure
• 21 CFR part 820, 801, 807, 803, etc.

• Knowledge of the Office suite.
• Knowledge of technical documentation management.
• Knowledge of mechanical drawing rules.
• Knowledge of project and planning management principles.
• Proactivity, excellent organizational skills, and the ability to work independently and in a team.

Compensation
Salary commensurate with experience (Gross Annual Salary: €35.000–€45.000).

Work Location

Merate (LC), Full Time Monday-Friday.

Who is Permedica S.p.A.

Permedica Spa is a leading Italian company in the orthopedic sector that develops, manufactures and markets joint prostheses and custom made solutions for the most complex cases, oncological orthopedics and amputees. From the main headquarters in Merate (LC), cutting-edge products are manufactured and distributed worldwide, thanks to subsidiaries and collaborators present on five continents.