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Regulatory Affairs Specialist
3 mesi fa
Job Title: Regulatory Affairs Specialist At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary We are looking for a Regulatory Affairs Specialist to join our Regulatory Team based in Pomezia (Rome). 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.
The Regulatory Affairs Specialist will develop a firm working knowledge of the following market and the regulations and standards associated:
Europe/Middle East/Africa (EMEA)
European Union: Medical Device Directive 93/42/EEC as amended by 2007/47/EC
EU MDR Regulation 2017/745
Key International Standards:
ISO 13485: Medical devices – Quality management systems
ISO 9001: Quality management systems
ISO 14971 Application of Risk Management to Medical Devices
Duties Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions.
Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorized.
Conduct daily activities of assigned job responsibilities and projects as assigned.
Support a safe, clean and secure working environment through adherence to applicable procedures, rules and regulations.
Assist in the updating and maintenance of essential requirements and GSPR checklists and technical files for products sold into the EU market. Complete change control documentation for regulatory related product changes.
Participate on project teams to provide regulatory input as assigned. Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization.
Execute regulatory affairs and compliance activities for company product lines in both the Italian and international markets in which the Company conducts business.
Provide support and on-site guidance as needed for regulatory compliance inspections/audits of the Italian facility.
Duties - cont'd Prepare, monitor and maintain documents for any submissions to NB and shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Prepare, compile, and submit regulatory documents for the registration of current and new products in some markets.
Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations.
Monitor approved registrations in respect to expiry and ensure management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.
Interact with Regulatory Affairs personnel at regulatory agencies, including NB, consultants, contract manufacturers, and distributors.
Work with in-country representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions.
Maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing STERIS products in a specified region.
Communicate applicable regulatory requirements to STERIS Regulatory Affairs management and business partners.
Analyze impact and communicate to management changes in regulations or requirements that have been identified.
Education Degree Bachelor's Degree in Biological Science
Required Experience Bachelor's Degree in Biological Engineering
Excellent PC skills, including Microsoft Office applications
Italian mother tongue and English fluent are mandatory
International regulatory experience
Ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action
Additional Information We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, sex, sexual orientation, gender identity, genetic information, and any other category protected by state or local law.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. STERIS strives to be an Equal Opportunity Employer.
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