Job Title:  Regulatory Affairs Specialist

Position Summary

We are looking for a Regulatory Affairs Specialist to join our team based in Pomezia, Rome.

He/she will have responsibility for performing the duties of the functional areas, as assigned, under the guidance and direction of his/her manager and other senior Regulatory Affairs staff. The mission of the STERIS Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market STERIS products in support of STERIS’s global business plans.

Duties

• Manage regulatory documents for the registration of current and new products
• Monitor pending submissions to ensure timely approvals
• Monitor approved registrations and ensure management is aware of action required to renew in a timely manner
• Interact with Regulatory Affairs personnel, including NB, consultants, contract manufacturers, and distributors
• Determine regulatory requirements for product registrations in responsible regions
• Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required

Education Degree

Required Experience

• A firm working knowledge of the following market and the regulations and standards associated: Europe/Middle East/Africa (EMEA): Medical Device Directive 93/42/EC, EU MDR Regulation 2017/745 ecc; Key International Standards; ISO 13485, ISO 9001, ISO 14971.

• At least 1 year prior international regulatory experience
• Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
• Excellent PC skills, including Microsoft Office applications. 
• Bilingual skills are highly desired, but not required.

Contract Condition

We will offer a permanent contract with a salary between 33k and 35k.