Regulatory Affairs Specialist
1 settimana fa
At Steris Canada Corporation, we strive to create a healthier and safer world by providing innovative healthcare and life science product and service solutions.
Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Team. The successful candidate will be responsible for implementing efficient and effective processes to obtain and maintain clearance to market Steris products in support of our global business plans.
Key Responsibilities- Maintain a firm working knowledge of market and regulatory requirements, including the European Union's Medical Device Directive and the EU MDR Regulation.
- Develop and maintain essential requirements and GSPR checklists and technical files for products sold into the EU market.
- Prepare, monitor, and maintain documents for submissions to regulatory agencies and shared drive folders.
- 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.
- Bachelor's Degree in Biological Science or related field.
- 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.
Steris Canada Corporation is 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.
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