Regulatory Relations Specialist jobs in Cape Coral, FL

• Ft Myers, FL. Support development & creation of regulatory documents in accordance with MDD, MDR ISO 13485 : 2016, FDA 21 CFR Part 820, MDSAP for medical device manufacturing company;
• conduct regulatory literature reviews for medical devices; develop & write procedures and provide written responses to audit findings;
• prepare usability files, risk management procedures, design control activities, complaint handling procedures, corrective & preventative action procedures, post market surveillance activities, management meetings;

lead quality audits; perform system-wide interviews to determine best course of action for procedure development. Master of Science in Regulatory Affairs for Drugs, Biologics & Medical Devices or related field req’d.

Drug testing & crim. background check req’d. Mail / fax / email resume to : Emcyte Corp, Attn : Patrick Pennie, 4331 Veronica S Shoemaker Blvd, Ste 4, Ft Myers, FL 33916 / fax : 239-481-7724 / email : [email protected]

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