RAQA Manager – Medical Device

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Job ID#: 26890

RAQA Manager – Medical Device
Direct Hire; up to 115K
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:
 

• Bachelor’s degree in sciences and/or relevant work experience
• Experience in regulatory affairs/quality assurance/product development and processes in 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

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