Lead Regulatory Affairs Specialist
NUVASIVE SOUTHEAST ASIA PTE. LTD.
Healthcare / Pharmaceutical
S$5000 - S$8500
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