Regulatory Affairs Intern

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78nt7b

Position Summary
We are looking for a candidate that will join our team as
Regulatory Affairs Intern (stage)
.
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.
This includes determining submission to NB for the CE marking and in some cases of registration and/or submission requirements in the International markets, working with STERIS International Registration staff to identify requirements in other targeted markets, and working with product acquisition or development teams to ensure these requirements are met.
This group also identifies and supports Regulatory Compliance needs.
Key International Standards
Europe/Middle East/Africa (EMEA)
European Union: Medical Device Directive *****/EC as amended by *******/EC and EU MDR Regulation ********
International Standards
ISO *****: Medical devices – Quality management systems;
ISO ****: Quality management systems;
ISO *****: Application of Risk Management to Medical Devices.
General Duties
Support compliance with corporate procedures and company policies.
Handle confidential information appropriately under supervision.
Assist with daily tasks and assigned projects.
Contribute to maintaining a safe and compliant work environment.
Support updates of GSPR checklists and EU technical documentation.
Assist with regulatory change control documentation.
Contribute to project teams with regulatory input.




Support regulatory requirements analysis and compliance activities.
Assist during audits and inspections as needed.
Support audits and inspections of the Italian facility.
Assist in preparing and maintaining documentation for NB submissions and databases.
Support preparation and submission of regulatory documentation for product registrations.
Assist in maintaining regulatory documentation to ensure CE marking compliance.
Monitor submission timelines and report potential delays.
Support interactions with regulatory bodies and stakeholders.
Assist in monitoring product changes and related documentation.
Education Degree
Bachelor's Degree in Engineering General or Biological Science
Work Requirements
Excellent PC skills, including Microsoft Office applications
Italian mother tongue and English fluent are mandatory
Training course in Regulatory Affairs (preferred)
Competencies
Self-starter that is highly organized;
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;
Strong oral and written communication skills.
Compensation
In line with our commitment to transparency and equal pay, we provide the following information:
Salary Range: 800€
NCBA: Chimica, Concia e Settori Accorpati, CONFAPI.
STERIS strives to be an Equal Opportunity Employer.
#J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78nt7b