Job Description

Regulatory Affairs Specialist

Frisco, TX


CornerStone Professional Placement has partnered with a reputable medical device manufacturing client seeking a Regulatory Affairs Specialist. As the Regulatory Affairs Specialist, you will be responsible for preparing regulatory submissions in compliance with ISO 13485 and FDA regulations. Qualified candidates will have their Bachelor’s degree in biomedical engineering or science, and have medical device regulatory affairs experience including experience with ISO 13485, and any experience with 501(k)s and EU technical files and CE markings is a plus. This is an exciting direct hire job opportunity to join a client that is revamping their Regulatory Affairs department so you will be in a high impact role! 


Requirements & Responsibilities for the Regulatory Affairs Specialist:

·        Bachelor’s degree in biomedical engineering or science

·        1+ years of Regulatory Affairs experience from the medical device industry

·        Experience preparing regulatory submissions in compliance with ISO 13485 and FDA regulations

·        Experience with CE markings (501ks and EU MDD) as well as experience maintaining technical files is a plus!

·        Strong critical thinking, problem solving, organization, and communication skills

·        W-2 only! No C2C, 1099, or visa sponsorship available! 


Compensation for the Regulatory Affairs Specialist

Direct hire

Schedule: Monday-Friday 8a-4p or 9a-5p

Pay: $65-80K/year (+/- based on experience)

Location: 100% on-site

Benefits: Medical, Dental, Vision, Life, AD&D, Disability, HSA, FSA, 401K w/ matching, Employee Assistance Programs, Tuition Reimbursement, Paid Holidays, Paid Vacation, and more!

Application Instructions

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