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Senior Regulatory Affairs Specialist in Redmond, WA at Stryker Corporation

Date Posted: 11/27/2018

Job Snapshot

Job Description

This job is an opportunity to join the Stryker Regulatory Affairs team located in Redmond, WA. 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.

MAJOR DUTIES/RESPONSIBILITIES:

  • Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), IDE, Design Dossiers 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 worldwide 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 direct daily activities of and mentor other members of the Regulatory Affairs team.
  • Perform other related duties as assigned.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Engineering, Biological Sciences or Allied Health Care.
  • Equivalent combination of education and experience is acceptable.
  • 5+ years of applicable Regulatory/Clinical experience.
  • Thorough understanding of: FDA medical device regulations, guidance, and import/exports requirements, labeling and promotional requirements; medical device quality systems; Product development processes; and clinical trial study design.

PREFERRED/DESIRED QUALIFICATIONS:

  • 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).

WORKING CONDITIONS:

  • Mission-oriented culture, energized by the knowledge that our products save lives every day, and our work has a 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.
  • Travel may be required.

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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