Hire Talent
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
About the company
HireTalent is an executive search firm and temporary staffing solutions provider that specializes in providing direct-hire, contract-to-hire, MSP staffing, Vendor Neutral Program staffing, and consulting services to clients at a national level. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000. #J-18808-Ljbffr
HireTalent is an executive search firm and temporary staffing solutions provider that specializes in providing direct-hire, contract-to-hire, MSP staffing, Vendor Neutral Program staffing, and consulting services to clients at a national level. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000. #J-18808-Ljbffr