Location: Seattle, WA
Job Type: Direct Hire
Salary: $125,000.00 - $135,000.00
Degree: Bachelor;
Date: 6/15/2017
Job ID: 02480248
Job Description
Redmond WA MedSurg and Neurotech?
GENERAL SUMMARY:?The Principal Regulatory Affairs Specialist develops and implements strategies for worldwide governmental approvals to introduce new and modified products to market, advises on regulatory requirements, prepares and/or supports worldwide regulatory submissions, and negotiates their approval. This role may work on highly complex submissions and have input to higher­level regulatory strategy decisions.
Prepare and/or support worldwide submissions for new products and product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager/VP as necessary and negotiate submission issues directly with agency personnel.
Work integrally with new product development and clinical research teams to provide support, guidance and planning to secure approvals for clinical investigations. Plan, coordinate and prepare document packages for regulatory submissions, including Class II and III U.S. FDA Pre­Market Approval (PMA), Pre­Market Notification (510(k)), Investigational Device Exemption (IDE), Design Dossiers, Shonins, Canadian Device License Applications, and internal “Letters to File.”
Support ongoing regulatory compliance activities to include regulatory assessment of product design or process change, preparation of annual reports, required PMA supplements, establishment license, and device listing renewals.
Negotiate directly with the FDA and other worldwide agencies on applicable products/projects.
Develop and implement global regulatory strategies for new and modified products.
Maintain submission correspondence files and other regulatory files in a complete and secure manner.
Create project deliverables, aligned with appropriate internal and external guidance documents.
Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
Review and sign­off on product, supplier, and manufacturing changes for compliance with applicable regulations. Support highly technical or major business segment products lines, special projects or strategic initiatives.
Provide regulatory input in quality system assessments.
Research new FDA and worldwide regulatory decisions or rulings and how they may affect the company's activities.
Conduct corporate training in GMP and other regulations. Support various internal compliance audits.
May have responsibilities directing daily activities of and mentoring less­senior members of Regulatory Affairs team.
Track and report worldwide registration status.?Implement process improvement projects within Regulatory Affairs. Perform other related duties as assigned.
Bachelor’s degree in Engineering, Biological Sciences or Allied Health Care. Equivalent combination of education and experience is acceptable.
8+ years of applicable Regulatory/Clinical experience
Med Device experience REQUIRED
PREFERRED/DESIRED QUALIFICATIONS: Thorough understanding of the following:
FDA medical device regulations, guidance, and import/exports requirements, labeling and promotional requirements
Medical device quality systems Product development processes
Awareness of international regulatory requirements and systems
Demonstrated management of regulatory submissions activities
Proficient in timely review of technical and clinical data
Computer skills; MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, database, graphics presentation applications, document processing/publishing tools
Detail oriented
Ability to work independently and with minimal supervision
Ability to mentor and provide work direction
Strong analytical skills required with the ability to analyze technical requirements and regulations which apply to the corporation
Strong organizational, interpersonal and communication skills (written and verbal)?Experience in Class I and Class II Medical Device Software products and device interoperability Clinical trial study design
Mission­oriented culture, energized by the knowledge that our products save lives every day, and our work here has a very material impact on the delivery of healthcare around the world.
Class III Medical Device, highly regulated environment?Normal office work environment?High volume communication role (email, voicemail, meetings)?Significant use of standard office equipment including computer keyboard, monitor, and mouse, and telephone May require long hours during peak project periods?Less than 10% travel may be required
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