Senior/consultant - Regulatory Affairs

5 days ago

Singapore IQVIA Full time

**ESSENTIAL JOB DUTIES AND RESPONSIBILITIES**:

- Provide Subject Matter Guidance in all aspects of Medical Device, In Vitro Diagnostic (IVD), Artificial Intelligence Medical Device, Standalone medical device software submissions etc.
- Assist head of regulatory services in assuming primary or secondary regulatory responsibility for assigned projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agencies across JAPAC.
- Delivering on regulatory projects in timely, proactive manner to ensure quality support. Managing projects by coordinating with IQVIA in country regulatory team leads.
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations. Review scientific data, publications, and related papers, etc., as appropriate for various regulatory projects to ensure compliance with regulations. (i.e. strategic guidance, dossiers preparation and submission activities in teams).
- Develop effective product registration strategies by performing critical review and gap analysis of product documentation.
- Establish relationships with regulatory agencies, health bodies, internal and external stakeholders.
- Undertake detailed review and management of budgets related to projects, including out of scope activities. Ensure revenue is recognized by managing professional activities and internal stakeholders’ finances allocation.
- Deliver training workshops and regulatory webinar to internal and external stakeholders, as supervised by Regulatory head. Identify business opportunities for regulatory projects
- Performs other tasks or assignments, as delegated by Regulatory head

**KNOWLEDGE, SKILLS AND ABILITIES**:

- Minimum of 6 years’ experience in an APAC Regulatory Affairs role in the medical devices industry.
- Demonstrates comprehensive regulatory or technical area of expertise. aptitude for activities related to regulatory affairs and quality compliance for products market access and maintenance, internationally. Familiarity with regulatory documents, general contents, organization and the methods of filing and tracking.
- Good interpersonal skills, negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach. Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Ability to work on several projects, retaining quality and timelines and can prioritise workload with mínimal supervision
- Ability to project manage and be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality maintenance.

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