Principal Regulatory Affairs Specialist in Redmond, WA at Apex Life Sciences

Date Posted: 4/28/2018

Job Snapshot

Job Description


Apex Life Sciences has a permanent opening for a Principal Regulatory Affairs Specialist with a leading medical device company in Redmond! Please see below for details and apply if interested!

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 higher ­level regulatory strategy decisions.

Major Duties/Responsibilities

  • 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 less ­senior members of Regulatory Affairs team.
  • Track and report worldwide registration status.
  • Implement process improvement projects within Regulatory Affairs.
  • Perform other related duties as assigned.

Minimum Qualifications

  • 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

Preferred 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

Working Conditions

  • 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 period.
  • Less than 10% travel may be required

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.