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Job Requirements of PMA Contractor Support:
-
Employment Type:
Contractor
-
Location:
Secaucus, NJ (Onsite)
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PMA Contractor Support
Careers Integrated Resources Inc
Secaucus, NJ (Onsite)
Contractor
Job Title: Regulatory Affairs Consultant – PMA (IVD Medical Devices)
Job Location: Secaucus, NJ (Remote)
Job Duration: 9-12 months
Shift: 8-5 day shift (M-F), flexibility in schedule if needed.
Pay Rate: $139.86/hr. on W2
Job Duration:
Key Responsibilities
Required Qualifications:
Preferred Qualifications:
Job Location: Secaucus, NJ (Remote)
Job Duration: 9-12 months
Shift: 8-5 day shift (M-F), flexibility in schedule if needed.
Pay Rate: $139.86/hr. on W2
Job Duration:
- We are seeking an experienced Regulatory Affairs Consultant to support a long-term project focused on Premarket Approval (PMA) submissions for In Vitro Diagnostic (IVD) medical devices.
- The ideal candidate will bring at least 5 years of direct, hands-on PMA experience, with strong expertise in authoring, compiling, and submitting all PMA modules. Experience with tissue-based IVD devices is highly desirable.
- This role requires close collaboration with cross-functional teams to gather technical, clinical, and manufacturing information and translate it into high-quality regulatory submission documents.
Key Responsibilities
- Lead and support authoring, drafting, and submission of all PMA modules for IVD medical devices.
- Provide hands-on regulatory expertise across end-to-end PMA submissions, including technical, clinical, and manufacturing documentation.
- Collaborate cross-functionally with R&D, clinical, quality, manufacturing, and labeling teams to gather required submission content.
- Ensure PMA submissions meet FDA regulations, guidance documents, and quality standards.
- Manage document development timelines to support project milestones.
- Support responses to FDA questions, deficiencies, and requests for additional information as needed.
Required Qualifications:
- Minimum 5 years of direct PMA regulatory affairs experience (medical devices / IVDs required).
- Proven hands-on experience authoring, drafting, and submitting all PMA modules.
- Strong working knowledge of FDA medical device and IVD regulatory requirements.
- Experience collaborating cross-functionally on complex regulatory submissions.
- Excellent written and verbal communication skills.
- Ability to work independently in a remote environment.
Preferred Qualifications:
- Experience with tissue-based IVD devices.
- Prior consulting or project-based regulatory experience.
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