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RA Specialist II

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RA Specialist II

  • Location:

    Malaysia

  • Sector:

    Monroe Health

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Julia Gonsalvez

  • Contact email:

    julia.gonsalvez@monroeconsulting.com.my

  • Job ref:

    BBBH436067_1702971223

  • Published:

    2 months ago

  • Expiry date:

    2024-02-17

  • Client:

    Monroe Consulting Group

Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading MNC company in medical devices. Our distinguished client is looking for an ambitious and experienced professional for the role of Regulatory Affairs Specialist II. The opportunity is a remote role based in Malaysia.

You will provide leadership in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and external parties such as regulatory bodies, regulatory consultants, and the ability to obtain and maintain regulatory filings, registrations, and compliance.

Job Responsibilities:

  • Collaborate with the R&D team to support new product development and oversee design control processes.
  • Conduct global regulatory assessments and identify regulatory pathways for new product development.
  • Secure regulatory verification and establish a global strategy for new product development.
  • Formulate regulatory filing strategies and submission types for diverse regulatory approvals and clearances on a global scale.
  • Develop, submit, and coordinate regulatory approval filings worldwide, encompassing 510(k), IDE, PMA, ANDA, NDA, Technical Files, and Design Dossiers in collaboration with internal teams.
  • Evaluate and make final determinations on regulatory assessments for proposed changes to existing products.
  • Stay informed about and interpret regulations and publications related to medical devices and PPE products, ensuring ongoing compliance.
  • Implement corrective actions to enhance product quality, streamline processes, minimize corporate exposure, and maximize profitability.
  • Ensures that all necessary quality assurance, regulatory and validation procedures, and policies are in place and up to date.
  • Ensure the presence and currency of quality assurance, regulatory, and validation procedures and policies.
  • Oversee the company's regulation and documentation programs, including the creation and distribution of standard operating procedures (SOPs), policies, and technical reports.
  • Direct and review self-audit and corrective action programs to maintain compliance with GMPs and Medical Device amendments.
  • Cultivate relationships with regulatory governmental agencies, both foreign and domestic, serving as a liaison.
  • Actively participate in and support continuous improvement and SOP initiatives to enhance productivity, profitability, and customer satisfaction in assigned areas.
  • Offer technical assistance and consultation to marketing, manufacturing, and customers on raw material selection, competitor product evaluation, and troubleshooting.
  • Review and approve promotional materials for use in designated markets.
  • Provide support to contracts and sales teams by supplying information on product registration status and addressing product characteristics requirements for contracts.


Requirements:

  • Bachelor's degree in biological sciences, microbiology chemistry or engineering required (Graduate studies in Regulatory Affairs is advantageous)
  • RAC certified professional and project management skills desirable.
  • More than 5 years of experience in Regulatory Affairs in the medical device industry.
  • Experience in dealing with the FDA, Notified Bodies, and other regulatory agencies is a must.
  • Working knowledge of ISO and applicable international regulations, compliance, and audit practices.