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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
