Intellectt Inc

Regulatory Affairs Associate

Intellectt Inc Alameda, CA
Intellectt Inc

Regulatory Affairs Associate

Intellectt Inc Alameda, CA
3 months ago
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Hello,

I Hope you are doing great.

This is Bhanu from Intellectt INC; we’ve got an important role Regulatory Affairs Associate - Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at bhanu@intellectt.com

Role: Regulatory Affairs Associate

Location: Alameda, CA

Duration: 12 Months

Shift Timings: 8 AM to 5 PM PST

Job Description

  • 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.

Thanks & Regards,

Ajay Bhanu

Intellectt Inc

Direct: 732 784 4384

Desk number : 732 412 6999- Ext: 159

517 Route 1 South, Suite 1115 Iselin, NJ 08830

WhatsApp: https://chatwith.io/s/bhanu

  • Seniority level

    Associate

  • Employment type

    Contract

  • Job function

    Legal

  • Industries

    Staffing and Recruiting

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