Philips Regulatory Operations Specialist in Bangalore, India

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Your Role

  • As a member of the Regulatory Operations team, the Regulatory Operations Specialist provides regulatory support for BG Ultrasound product lines and is responsible to build and deliver on competitive regulatory strategies

  • The Regulatory Operations Specialist works directly with regulatory agencies to achieve the best possible outcomes for effective product market clearances

  • He / She is responsible for the coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc..) and to recommend strategies for clinical studies and evaluations

Your responsibilities

  • Is the Regulatory Operations representative for BG Ultrasound and assists with regulatory issues related to such items as labelling, SharePoint management, and international communications with internal and external stakeholders

  • Prepares documents required in the Development Life Cycle, and recommends strategies for the most efficient and effective approvals of regulatory applications for the business

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure the regulatory strategy is in alignment with company objectives

  • Plan, generate and coordinate implementation of global medical device labelling related projects

  • Coordinate and prepare document packages for regulatory submissions to global regulatory agencies and/or competent authorities [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, US Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for all manufacturing sites

  • Maintain existing regulatory filings/licenses, managing updates and related change control processes

  • Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.

  • Provide audit and CAPA support

Skills & Experience you bring to the role

  • Bachelor’s degree in a technical/healthcare/business discipline or equivalent

  • 2-3 plus years of relevant experience in a medical device company (FDA Class I or II equivalent – Class III a plus)

  • Experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide

  • Working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601, ISO14155, and other related particular standards. Excellent English skills (written and oral)

  • Knowledge of nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies

Desired Qualifications:

  • Certified regulatory affairs professional would be desirable

  • Experience with medical device labelling strongly preferred

  • Experience working in SharePoint environments

  • Experienced in the design control process