Regulatory Affairs Specialist (121) Bothell, Washington
Regulatory Affairs Specialist - Verathon®
Verathon® is looking for a Regulatory Affairs Specialist to become the newest member of RA Team located in our Bothell, WA headquarters.
The Regulatory Affairs Specialist is responsible for the preparation and coordination of documentation packages for regulatory submissions, license renewals, annual registrations and approvals in the domestic and international markets. Other tasks including monitoring and improving tracking systems and participating as a regulatory representative on project teams and change controls. The ideal candidate must be able to demonstrate knowledge of regulatory procedures, changes and regulations.
- Coordinate and prepare regulatory documentation packages for submissions, including 510(k), significant change notifications, license renewal and annual registrations for the US, EU, Canada and Global.
- Create and maintain Essential Requirements Checklist, CE Technical File and Declarations of Conformity for all products CE marked, and provide information for all global registrations.
- Maintain tracking system of clearances, license renewal and annual registrations for medical device submissions including US, Canada, EU and Global.
- Provide information and material for Certificate to Foreign Government (CFG), Certificate of Exportability (COE), Medical device listings for FDA and all required legalization documentation per global requirements.
- Manage document coordination, retrieval and retention of regulatory submissions and data files.
- Participate on product development teams to ensure regulatory requirements are incorporated as part of the development process.
- Review and approve engineering change orders, deviations, and corrective actions for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance and impact to existing regulatory licenses.
- Provide department support during FDA, ISO and other external audits.
- Identify and develop Regulatory Affairs processes and procedures.
- Demonstrate continuous regulatory knowledge in product submissions and regulatory topics for medical devices, including 510(k), labeling, MDD 93/42/EEC, 21 CFR 820, global registrations and technical writing.
- Provide continual regulatory updates to the Management team to ensure alignment and support.
Knowledge, Skills, and Abilities:
- Bachelor’s degree in Science, Engineering or related field.
- Minimum of 3-5 years of experience in regulatory affairs with emphasis on Medical Device experience.
- Excellent working knowledge of domestic and global regulations, including solid experience in 510(k) submissions.
- Experience with Design control process, Quality System requirements and standards.
- Highly effective at working with cross functional teams from diverse disciplines and culture with all internal and external customers related to this position.
- Proficient with technical system skills (MS-Applications, databases and online research tools)
- Strong organizational skills and attention to details.
- Ability to communicate effectively, verbally and in writing.
- Competent to set priorities and manage multiple tasks.
- Problem solving and analytical thinking abilities required.
- Maintain training in Regulatory requirements and regulations.
- 5% travel may be required.
Verathon is a wholly owned subsidiary of Roper Industries, an acquisitive S&P 500 and NYSE listed diversified growth company. Verathon is headquartered in the greater Seattle area, in Bothell, Washington, and has 7 international subsidiaries in Canada, Europe and Asia. The company designs, manufactures, distributes and markets reliable, state-of-the-art medical devices and services to the health care community that offer meaningful improvement in patient care. Our largest brands, BladderScan and GlideScope, have achieved worldwide recognition as the number one leader in their respective markets. Verathon is a financially sound company with consistent growth and performance even during down market cycles. We have a strong pipeline of new products for multiple areas of discipline within the health care industry.
Verathon was acquired by Roper Industries (US Ticker symbol ROP) in December 2009 as a platform for future acquisitions leveraging the talented management team and extraordinary channel development in developed country markets.
Verathon offers competitive compensation and a complete benefits package to full-time employees including company sponsored health plan, 401k with match, wellness and tuition reimbursement and the advantages of an environment that supports your development and recognizes your achievements.
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.