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EmCyte Corporation
Fort Myers, FL | Full Time
$73k-95k (estimate)
1 Week Ago
Regulatory Affairs Specialist II
EmCyte Corporation Fort Myers, FL
$73k-95k (estimate)
Full Time | Business Services 1 Week Ago
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EmCyte Corporation is Hiring a Regulatory Affairs Specialist II Near Fort Myers, FL

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  • 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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17 hours ago

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$73k-95k (estimate)

POST DATE

05/03/2024

EXPIRATION DATE

05/10/2024

WEBSITE

emcyte.com

HEADQUARTERS

Fort Myers, FL

SIZE

<25

INDUSTRY

Business Services

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The following is the career advancement route for Regulatory Affairs Specialist II positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist II, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist II. You can explore the career advancement for a Regulatory Affairs Specialist II below and select your interested title to get hiring information.