Lead Regulatory Affairs Specialist

  • Job Category
    Healthcare / Pharmaceutical
  • Job level
  • Contract type
    Full Time
  • Location
  • Salary
    S$5000 - S$8500

Job Description

As a Regulatory Affairs Specialist at NuVasive, you are responsible for assisting with product submissions globally, with a focus on products containing software. Each day offers exciting new challenges as you tackle a variety of tasks including:

  • Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
  • Ability to determine and communicate submission and approval requirements to others.
  • Control and maintain regulatory records.
  • Represent Regulatory Affairs on various design and development teams by attending team meetings and providing the required plans, procedures, and regulatory decisions.
  • Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs.
  • Evaluate the regulatory impact of the proposed product and/or process changes, and determine if a new pre-market application is required.
  • Ability to lead & organize project meetings and coordination of tasks to obtain required deliverables.
  • Responsible for assisting Engineering in the maintenance of Design History Files and related records on an as-needed basis, and where regulatory responsibilities permit.
  • Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
  • Demonstrates global regulatory expertise in product submissions and ability to evaluate changes with local regulations.
  • Perform other duties as assigned.
  • Understanding of regulatory terminology, pre-market submission types, and requirements.
  • Basic understanding of regulatory requirements throughout the product lifecycle.
  • Knowledge of appropriate Quality System Requirements (QSR) for Singapore and across South East Asia.
  • Knowledge of applicable ISO requirements in region.
  • Knowledge of labeling requirements.
  • Must be detail-oriented & highly organized.
  • Must demonstrate team-building skills in & outside the department.
  • Ability to exercise judgment.
  • Ability to prioritize workload with limited direction.
  • Proactively assembles necessary information and establishes informal working networks within the company to solve departmental challenges.
  • Understands requirements of project plans and focuses activities on meeting plan objectives.
  • Typically requires a Bachelor’s degree and a minimum of 5 years of related experience; or an advanced degree without experience; or equivalent work experience.
  • 3+ years of related experience, specifically in the medical device industry with a focus on software devices and mechanical electrical equipment preferred.

Closing on 22 Dec 2021