Regulatory Affairs Specialist Job - (flower mound, texas)
Job Title:
Regulatory Affairs Specialist Division:
Endoscopy Business Unit:
Communications Business Function:
Regulatory Affairs Business Sub Function:
Regulatory Affairs Country:
United States State:
TX City:
Flower Mound Shift:
1st
Job Description:
POSITION DESCRIPTION:
Under general supervision of the RA Department Manager:
:
Participate on product development teams to insure US and other international regulatory requirements are incorporated as part of the development process :
Ensure compliance with FDA regulatory requirements in regards to 510(k)s, labeling, and listings :
Address and advise teams on appropriate pathways to market :
Review and approve labeling and literature for regulatory compliance, pre and post market :
Ensure compliance with global regulations (specifically, Medical Device Directive) in regards to creation and maintenance of Product Technical Files and Design Dossiers, as applicable :
Assist in post market submissions :
Support marketing, R and D and manufacturing teams in regulatory assessments of proposed changes or product transfers :
Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues :
Interpret existing and/or new regulatory requirements as they relate to company products and procedures :
Assist the RA Manager and others with the development, implementation and maintenance of regulatory SOPs :
Complaint review and adverse event reporting EDUCATION/
Qualifications:
:
Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
:
RAC certification desired :
3 :
5 years Regulatory Affairs medical industry experience, preferably with medical devices.
:
Thorough understanding of FDA and international medical device regulations.
:
510(k) preparation experience or training preferred :
General understanding of product development process and design control.
:
General understanding of Corrections and Removals :
Proficiency with Microsoft Office.
:
Ability to manage multiple projects.
:
Effective written and oral communication, technical writing and editing skills.
:
Ability to work independently with minimal supervision.
Qualifications/Work
Experience:
Percent Travel Required:
0 Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Regulatory Affairs Specialist Division:
Endoscopy Business Unit:
Communications Business Function:
Regulatory Affairs Business Sub Function:
Regulatory Affairs Country:
United States State:
TX City:
Flower Mound Shift:
1st
Job Description:
POSITION DESCRIPTION:
Under general supervision of the RA Department Manager:
:
Participate on product development teams to insure US and other international regulatory requirements are incorporated as part of the development process :
Ensure compliance with FDA regulatory requirements in regards to 510(k)s, labeling, and listings :
Address and advise teams on appropriate pathways to market :
Review and approve labeling and literature for regulatory compliance, pre and post market :
Ensure compliance with global regulations (specifically, Medical Device Directive) in regards to creation and maintenance of Product Technical Files and Design Dossiers, as applicable :
Assist in post market submissions :
Support marketing, R and D and manufacturing teams in regulatory assessments of proposed changes or product transfers :
Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues :
Interpret existing and/or new regulatory requirements as they relate to company products and procedures :
Assist the RA Manager and others with the development, implementation and maintenance of regulatory SOPs :
Complaint review and adverse event reporting EDUCATION/
Qualifications:
:
Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
:
RAC certification desired :
3 :
5 years Regulatory Affairs medical industry experience, preferably with medical devices.
:
Thorough understanding of FDA and international medical device regulations.
:
510(k) preparation experience or training preferred :
General understanding of product development process and design control.
:
General understanding of Corrections and Removals :
Proficiency with Microsoft Office.
:
Ability to manage multiple projects.
:
Effective written and oral communication, technical writing and editing skills.
:
Ability to work independently with minimal supervision.
Qualifications/Work
Experience:
Percent Travel Required:
0 Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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