3BMedical Inc. d/b/a React Health in Bothell, WA has an opening for a Sr. Regulatory Affairs Specialist to:
- Prepare and maintain regulatory submissions, maintain 510k product registrations;
- Approve design/manufacturing changes; Analyze product changes for impact to current regulatory filings
- Maintain current standards list; Identify and lead projects to comply with latest standards (FDA expectation)
- Regulatory Intelligence: Monitor regulatory environment (FDA). Provide regulatory environment update in Management Reviews;
- Primary point of contact for FDA interaction (questions/responses); Participate in FDA inspection as needed.
- Recall administration;
- Participate in/lead internal audits;
- Stay current on international regulatory requirements and lead appropriately regulatory approvals; Lead CE mark requirement definition/implementation;
- Support maintaining a c GMP compliant Quality Management System to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, c GMP, (MDD 93/42/EEC, MDR 2017 /745,) and ISO 13485 regulatory requirements;
- Develop relevant regulatory procedures and work instructions as necessary;
- Lead audit readiness initiative. Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance;
- Attends and participates in departmental meetings;
- Attends seminars and training sessions necessary to maintain appropriate level of professional competence;
- Ensures all department compliance guidelines are met;
- Attends all meetings, in-services training, or continuing education as delegated by the supervisor;
- Provides customer focused interactions;
- Performs all duties necessary for the department as per department policies and procedures;
- Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.
Telecommuting allowed.
Must have a Bachelor’s Degree in Regulatory Affairs, Engineering or Life Science discipline & 60 mo exp.in regulatory affairs OR a Master’s degree in Regulatory affairs, Engineering or Life Science discipline & 36 mo. exp.in Regulatory Affairs.
Wage offered is $133,707.08. Standard company benefits. Telecommuting from anywhere in US allowed. Send resumes to sara.morano@reacthealth.com.
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