Job Description

The Senior Quality & Regulatory Operations Specialist will support regulatory and quality operations across the JPAC region to ensure compliance, operational efficiency, and commercial readiness. This role partners closely with Commercial, Quality, and cross-functional teams to support tender submissions, maintain compliance with regional regulations, and ensure products and processes meet applicable regulatory and quality requirements.

The individual will combine regulatory knowledge, quality systems expertise, and operational execution to identify gaps, develop compliant solutions, and enable business growth across diverse markets. This role requires strong understanding of JPAC regulatory frameworks, quality management systems, and the ability to translate evolving requirements into practical, business-aligned actions.

Duties & Responsibilities

Support execution of RA/QA operational activities across JPAC markets to ensure compliance and business continuity.
Drive regulatory and quality support for tenders, including requirement review, documentation preparation, and gap assessments.
Partner with Commercial teams to ensure timely and compliant tender submissions and competitive positioning
Support setup and maintenance of distributor, importer, or economic operator registrations across JPAC markets
Maintain compliance with regional regulatory requirements, providing input and support to regulatory submissions and lifecycle activities
Coordinate and maintain regulatory documentation and records, ensuring alignment with local and global requirements
Support implementation and maintenance of Quality Management System (QMS) processes (ISO 13485), including CAPA, change control, deviations, and audit readiness
Participate in internal and external audits, supporting compliance activities and inspection readiness
Ensure compliance with labeling and claims requirements, partnering with internal teams to drive updates and approvals
Develop regulatory justifications, compliance memos, and supporting documentation where gaps exist to meet tender requirements
Monitor evolving regulatory requirements across JPAC and translate into actionable operational guidance for the business
Collaborate cross-functionally with Quality, Clinical, R&D, Supply Chain, and Commercial teams
Support regulatory operations systems (RIM/eQMS), ensuring accurate data, documentation control, and reporting
Drive process improvements and standardization to enhance regulatory and quality operations efficiency
Support product lifecycle activities including changes, renewals, and market expansions.

Minimum & Preferred Qualifications And Experience

A minimum of 2 years of work experience in a medical device Class II/ III environment.
Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
Advanced degree preferred
3-5+ years of regulatory affairs and/or quality assurance experience within the medical device or healthcare industry
Strong experience supporting JPAC regulatory and quality frameworks
Working knowledge or involvement in regulatory submissions and lifecycle activities
Hands-on experience with Quality Management Systems (ISO 13485), including CAPA, audits, and change control
Experience in setting up distributors, legal entities, or economic operator structures is highly preferred
Strong understanding of JPAC regulatory and quality frameworks (e.g., CDSCO, PMDA, TGA, HSA, NMPA)
Proficiency in regulatory and quality IT systems (e.g., RIM, eQMS)
Strong cross-functional collaboration and stakeholder management skills
Ability to work in fast-paced, ambiguous environments with agility
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Ability to influence without authority and drive alignment across teams
High attention to detail and commitment to compliance

Sr. Quality and Regulatory Operations Specialist