RAQA Specialist - Medical Device Job at Professional Alternatives, Sugar Land, TX

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  • Professional Alternatives
  • Sugar Land, TX

Job Description

Job ID#: 26891

RAQA Specialist – Medical Device industry
Direct Hire; up to 80K
Sugar Land

Duties:

  • Research and provide recommendations to product teams on appropriate regulatory pathways to market
  • Participate in teams to ensure appropriate global regulatory requirements are incorporated as part of development and design change process for both new and existing products
  • Research, author, or provide support for regulatory
  • Coordinate with Notified Bodies, Competent Authorities, and other regulatory agencies on  submissions, audits, approvals, or other issues
  • Interpret existing and/or new regulatory requirements relating to products and procedures; communicate to personnel
  • Provide marketing and literature review pre and post market
  • Research, author, or provide support in preparation and updates to Technical Files
  • Assist with development, implementation, and maintenance of regulatory SOP’s and development/improvement of processes and procedures
  • Participate in RA related parts in site audits and routine RA maintenance activities

Qualifications:

  • High school diploma required; some college and work experience
  • Experience in regulatory affairs/quality assurance/product development and processes in the medical device industry; regulatory audits and inspections
  • International regulations and standards (CFR, MDD, MDR, QSR, ISO 13485, MDSAP, etc.)
  • USA (federal, state, and local) and International product registrations (CFG’s, apostille, and consularization processes); medical device import and export requirements
  • Technical writing and creating reports, SOPs, etc.; strong Microsoft Office Suite
  • Organized, analytical, keen eye for detail, strong communication, business acumen,
  • Team player, collaborative, and positive approach; independent, self-starter

Other Info:

  • Business casual attire
  • Thriving and growing organization recently involved in acquisitions; 160 team members
  • Well-rounded benefits package
  • Amazing company culture – collaborative, fun, down to earth, engaging, and approachable and motivating senior leadership
  • Some travel may be required

Founded in 1998, Professional Alternatives is an award-winning recruiting and that utilizes technology and relationships to deliver top talent.  Connect with us today!

Job Tags

Work experience placement, Casual work, Local area,

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