Sr. Regulatory Associate – Physiology

New

 

Adecco is currently assisting a local client in their search to fill a Sr. Regulatory Associate-Physiology job in Redmond, WA.  Apply now if you meet the qualifications listed below!

 

Type:                     Fulltime (40 hours / week) contract

Length:                 1 year+

Pay:                       $57.00-$65.00/ HR Based on Experience

Shift/Hours:       8A – 5P

 

Responsibilities for this Sr. Regulatory Associate position include but are not limited to:

This role will focus on the changes required for the European Medical Device Regulation (EU MDR). Robust understanding of the current EU Medical Device Directive (MDD) is a required qualification and understanding the EU MDR is highly preferred. Composition and maintenance of technical documentation to support CE Mark (Technical Document File and Declaration of Conformity) is required. This role will focus the transition of current technical documentation from MDD to MDR. Experience with TUV or other Notified Bodies is strongly desired

  • Plan, coordinate and prepare document packages for regulatory submissions, focusing on CE Mark documentation.
  • Support submissions and ongoing regulatory compliance activities for the product development process.
  • Communicate directly with Notified Bodies and other worldwide agencies on applicable products/projects.
  • Develop and implement 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 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 worldwide regulatory decisions or rulings and how they may affect the company's activities.
  • Communicate with different functional areas within company to gather information necessary for submissions
  • Perform other related duties as assigned

 

Qualifications for this Sr. Regulatory Associate position:

  • Bachelor’s degree in Engineering, Biological Sciences or related field.
  • 5+ years of applicable Regulatory/Clinical experience.
  • Equivalent combination of education and experience is acceptable.
  • Adequate understanding of:
    • European medical device regulations, guidance, and import/exports requirements, labeling and promotional requirements;
    • medical device quality systems; and product development processes.
  • Strong analytical skills required with the ability to analyze technical requirements and regulations which apply to the corporation.
  • 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.
  • Strong organizational, interpersonal and communication skills (written and verbal)

 

 

 

 

Why work for Adecco?

  • Weekly pay
  • 401(k) Plan
  • Skills Training
  • Excellent medical, dental, and vision benefits

 

IMPORTANT: This Sr. Regulatory Associate job is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “Apply with Adecco” button to submit your resume.

 The Adecco Group is a global leader in HR services.  Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world.  We offer employment opportunities at any stage in your professional career.  Contact us today to discuss available contract and direct hire positions.  Adecco Group provides one of the most comprehensive benefits packages in the industry to contract workers to include Holiday, 401(k), Insurance Benefit Plans

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Adecco will consider qualified applicants with arrest and conviction records for employment

  • Apply with Adecco

Reference number US_EN_99_022862_1208531