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Regulatory Affairs Specialist II
Technical Writer
Bothell, WA

Experience: Minimum 15 years professional experience in the applicable role. Education: Education: Bachelor's /Master's degree or equivalent.

Expert and technical lead with proven experience.

Supports regulatory compliance performing the required activities that assure compliance with FDA regulations for class III products.

Is a subject matter expert in RA for new products, familiar with product clearances, establishing licenses, maintaining files, communicating changes, evolving regulatory landscape, quality system procedures.

May handle or support regulatory requests from regulatory agencies, prepare and submit product registrations and submissions to FDA and other regulatory bodies, maintain registrations and device listings, support the reporting of departmental metrics, support and backup for other Q&R functions, supports internal/external audits and regulatory inspections.

Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.

Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.

Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.

Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project, Provide significate regulatory support to ongoing PMA activities.

 

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