Senior Regulatory Specialist, Compliance and Operations Support Manager

Senior Regulatory Specialist, Compliance and Supply-Chain (Operations) Manager

A senior regulatory specialist, compliance and quality support manager position is available at Respiree Pte Ltd. The purpose of this role is to manage regulatory aspects and quality compliance of the medical devices for hospitals and healthcare stakeholders.

Responsibilities:

Manage regulatory submissions and product registrations
Manage technical file and design history file updates
Manage quality compliance and assurances of product
Manage quality verification of new product pipeline via interactions with product development team
Ensure compliance to ISO 13485 standards and maintain documentation
Manage the quality and customer support efforts
Facilitate product development efforts with inputs from customer support
Following quality compliance and adherence trends locally and internationally
Develop close working relationships with international partners
Manage operations and supply-chain management
*

Requirements:

Degree in Life Science, engineering or related discipline
Degree in Business or related discipline is a bonus
3-5 years of experience in healthcare operations and regulatory compliance
Knowledge of the life-science and/or healthcare sector within APAC
Strong analytical, management and communication skills
Driven personality
Strong influencing skills
Additional Details:

Type of employment: Full-time/Part-time
Place of deployment: Respiree Pte Ltd
Other opportunities: exposure to sales and marketing team