Senior Regulatory Affairs Specialist

Location: Seattle, WA
Job Type: Direct Hire
Salary: $74,000.00 - $96,600.00
Degree: Bachelor;
Date: 9/15/2017
Job ID: 02512686
Job Description
The Senior Regulatory Affairs Specialist develops strategies for worldwide governmental approvals to introduce new and modified products to the market, advises on regulatory requirements, prepares worldwide regulatory submissions, and negotiates product approval.
  • Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), PMA, IDE, Design Dossiers, Shonins, Canadian Device License Applications, and internal “Letters to File.”
  • Support submissions and ongoing regulatory compliance activities for the product development process.
  • Negotiate directly with the FDA and other worldwide agencies on applicable products/projects.
  • Develop and implement regulatory strategies for new and modified products.
  • Responsible for foreign registrations and “Permission to Export” documents.
  • 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.
  • Maintain annual facility registration and device-listing documents.
  • Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
  • Review and sign-off on product 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 world-wide regulatory decisions or rulings and how they may affect the company's activities.
  • Conduct corporate training in GMP and other regulations.
  • Conduct various internal compliance audits.
  • May have responsibilities directing daily activities of and mentoring less-senior members of Regulatory Affairs team.
  • Perform other related duties as assigned.
Minimum Qualifications

  • Bachelor’s degree in Engineering, Biological Sciences or Allied Health Care.
  • 5+ years of applicable Regulatory/Clinical experience

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
  • Clinical trial study design
  • 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)
  • Mission-oriented 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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