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Sr. Regulatory Affairs Specialist

Redmond, Washington 98052 | Contract

Post Date: 02/21/2018 Job ID: 18109 Industry: Hardware

Position Title: Sr. Regulatory Affairs Specialist

Position Description: Our Eastside client is looking to add a Sr. Regulatory Affairs Specialist to their team.

Experience/Minimum Requirements:
  • Minimum 5 years of experience working for a medical device company in regulatory affairs
  • Creating and maintaining technical files compliant to MDD 93/42/EEC (for Class I and Class IIa devices)
  • Generating risk management annual reports compliant to ISO 14971
  • Familiarity with MEDDEV 2.7/1 revision 4
  • Ability to work independently and amongst a team with minimal supervision.
  • Effective problem solving with a high attention to detail.
  • Excellent computer and presentation skills including Microsoft Word, Excel, and PowerPoint.

Preferred Experience
  • Generating clinical evaluations compliant to MEDDEV 2.7/1 revision 4
  • Reviewing protocols & reports for cleaning and sterilization validations
  • Research methodology
  • OBL certification processes related to technical files

Required Competencies:
  • Strong organizational and time management skills.
  • Work effectively on cross functional teams.
  • Ability to lead investigations to resolve quality issues.
  • Excellent written and oral communication skills.
  • Ability to review, analyzes, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.

Primary Duties & Responsibilities:
  • Update technical files for compliance
  • Generate risk management annual report
  • Other duties as required

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.

Laura Garcia

I am a recruiter who works with people over the span of their careers. I have worked in Technical staffing for 17 years in the Puget Sound area primarily as well as nationally. I specialize in working with Technical/Engineering professionals in any area of Hardware or Software product development. I listen to what you are looking for, I am honest, forthright in giving feedback, and responsive and communicative through the hiring process. I am passionate about putting Vets back to work and Minorities in Engineering roles.

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