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About our client
Our client represents one of the most significant market opportunities in the medical device industry today. Their aim is to develop, manufacture, and market advanced products such as spinal cord stimulation (SCS) to improve the quality of life for people who suffer with disabling pain or nervous system disorders.
Position	Location
Senior Regulatory Affairs Manager	Texas
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Implement international and domestic regulatory strategies 2) Develop international and domestic regulatory submission strategies 3) Prepare 510 (k)s PMAs and IDEs submission applications 4) Conduct device research to support regulatory submissions 5) Prepare international regulatory filing and registration documentation 6) Participate on development and clinical trial teams 7) Prepare design dossiers for review by notified body 8) Submit product registrations and applications to foreign governments as required, i.e. TGA 9) Review and approve advertising and promotional materials for regulatory implications 10) Participate in and contribute to project teams
Requirements
1) Bachelor of Science degree in a related field 2) Minimum 5 years of experience in regulatory affairs and quality assurance 3) 5+ years of experience in submitting IDEs, 510 (k)s and PMAs 4) Background in devices is preferred 5) Familiarity with implantable device submissions