Diasorin · 4 hours ago
Senior Regulatory Affairs Associate
United States
Full-time
Remote
Mid, Senior Level
4+ years exp
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No H1B
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Responsibilities
Prepare 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II and III medical devices.
Prepare and assist in review and submission of regulatory submissions, product registrations and technical dossiers to Notified Bodies and Health Canada.
Prepare appropriate documentation for product CE mark certification.
Maintain regulatory documentation, registrations and device listings for both domestic and outside the US (OUS). Maintain international regulatory submission technical files, registrations/licenses, device listings and design dossiers for CE marking, and those required for Canada and other international countries outside the US.
Interact effectively with functional business units in order to facilitate documentation requirements for submissions, ensuring that departmental timelines are met. Communicate and coordinate regulatory activities with other departments.
Prepare and evaluates regulatory documents and company specific SOP's to maintain FDA QSR and ISO 13485 compliance.
Provide appropriate regulatory guidance to research and operations staff.
Review and provide input to device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
Review of product and manufacturing changes and compliance with applicable regulations.
Review of protocols and reports to support regulatory submission and product changes.
Participate on interdepartmental teams where required, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files.
Participate in compliance activities that relate to the department and the company as a whole.
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
Write/revise departmental SOPs as required
May assist with training and mentoring other RA associates and staff
Other duties as assigned
Qualification
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Required
Bachelor's Degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology or equivalent
4+ years Experience in a GMP and/or FDA regulated environment, medical device industry or equivalent
4+ Years Experience as a Technician / Scientist or related biological discipline
1+ Years Experience with in vitro medical devices
1+ Years Experience working independently in a fast-paced environment with rapidly changing priorities
Thorough knowledge of cGMP regulations and ISO13485 standard for quality management systems
Ability to effectively contribute to and lead cross-functional project teams
Strong written and oral communication skills
Highly organized and detail –oriented with exceptional proven time management and prioritization skills
Results and goal oriented Ability to work independently and with minimal supervision in a fast paced and dynamic environment
Ability to handle the pressure of meeting tight deadline
Preferred
Master’s Degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology or equivalent
Certification in Regulatory Affairs/Quality considered to be an asset (RAQC, RAC, ASQ CQA, etc.)
Company
Diasorin
DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Doug Schuenke
CFO and VP Finance
Davide Marietta
Corporate CIO
Recent News
TradingView
2024-11-05
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