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Regulatory Affairs Specialist

Company: Amick Brown, LLC
Location: Sunnyvale
Posted on: April 8, 2021

Job Description:

Amick Brown is seeking an experienced--Regulatory Affairs Specialist 1 for our direct client.

Location: Sunnyvale, CA
Duration: 1 Year
--
Roles and Responsibilities
The candidate should have at least 3-4 years' experience in Regulatory Affairs:
--

  • Understand our client products and India Regulatory requirements, more specifically submission requirements
  • Coordinating the review of Power of Attorney by SMEs for products manufactured by each manufacturing site
  • Facilitate discussions with SMEs during PoA review
  • To follow-up and have independent meetings with SMEs to complete the PoA review
  • Coordinate the timely review of Device Master File by SMEs for each product
  • Identify, facilitate & participate in discussions of India team with SMEs during DMF review
  • To follow-up and have independent meetings with SMEs to complete the DMF review
  • In case of multiple SMEs, collaborate with each SME to get their comments for DMF
  • Coordinate with India team & SMEs at SV for finalization of DMF
  • Coordinating the review of Plant Master File by SMEs (Quality Engineers) for each manufacturing site as per the specified timelines
  • Identify, facilitate & participate in discussions of India team with SMEs during PMF review
  • To follow-up and have independent meetings with SMEs to complete the PMF review
  • In case of multiple SMEs, collaborate with each SME to get their comments for PMF
  • Coordinate with India team & SMEs for finalization of PMF
  • Apostille, Notarization & Signing of PoA, Undertakings, Certificates, DMFs, PMFs and any other document as required
  • Identify and obtain Sign offs from the Authorized Representative or appropriate stakeholder for DMF, PMF and any other documents
  • Coordinate and obtain notarization of the documents like DMF and PMF, and specific documents as required
  • Coordinate notarizations of various certificates like CE, ISO, FSC & / manufacturing license from COO, Establishment certificates etc.
  • Coordinate for obtaining Apostille of documents in a timely manner
  • Follow-up regarding the status of Apostille from the Embassy
  • Share the scanned copy of the signed document Notarized/ Apostilled (hard copy through courier) with India RAQA team
  • Coordinate with different Global stakeholders for completion of submission application
  • To follow-up with the Post Market Surveillance team for timely availability of PMS data, CAPA, Recall information and any clarifications required
  • To follow-up with the Product Quality team for timely availability of CoAs
  • To follow-up with OEM resources for timely availability of information / documents / certificates etc.
  • To follow-up with designated people for getting Global marketing data (Global & India import & sales)
  • To follow-up with designated people for getting GHTF approval details
  • To follow-up for any other regulatory related information required by India teamAmick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

    Regular full-time employees are eligible for the following Amick Brown provided benefits:--
    • Health
    • Vision
    • Dental
    • 401k with company match
    • Paid time off
    • Sick Leave
    • Short-Term Disability
    • Life Insurance
    • Wellness & Discount Programs--
      --

Keywords: Amick Brown, LLC, Sunnyvale , Regulatory Affairs Specialist, Other , Sunnyvale, California

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