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Regulatory Affairs Associate

1 month ago

Johor Bahru, Malaysia Hemo Bioengineering Pte Ltd Full time

Objective:
Responsible for the management of regulatory submissions for new product registration as well as the notification of change of existing products registered in the APAC, European and US region, whilst ensuring compliance with the relevant legislation, industry standards and Company policies.

Key Responsibilities:

- Manage independently all government product registrations/ change notifications/ re-registrations/ license renewals/ input requests-questions and other related actions to ensure timely initiation and closures per internal and regulatory deadlines to be in line with product launch/business plans.
- Prepare, submit, and follow up with consultations on applicable regulations on company products and processes.
- Support customers/ dealers/ partners in our markets likewise where company entity is not the product holder and ensure their timely registration/ license renewal success.
- Maintain regulatory trackers and manage the filing and record keeping of regulatory documentation.
- Implementing quality strategy and strategic operational goals to meet quality objectives
- Thorough understanding of the legislation and medical device standards in our target markets to ensure best business outcomes.
- Identify and assess potential changes to relevant legislation and medical device standards within our target market regions and effectively communicate the impact to key stakeholders.
- Supporting Post Market Activity (PMS, PSUR annual updates) and ensuring timely and correct reporting/ follow up to authority.
- Keeping abreast of regulatory procedures and changes in the regions, advise and strategize with upper management, keeping them informed of the regulatory development and advising on the methods to execute contingency methods as needed.
- Responsible for coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections and attending to external auditor.
- Develop and review internal policies that relating to the manufacturing, testing, sales & marketing and reliability of products to ensure compliance of the regulatory requirements.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Acts as a core member on manufacturing and remediation teams, providing regulatory feedback and guidance throughout the program, and coordinating team inputs for submissions.
- Establish and support a work environment of continuous improvement that supports Company's Quality Policy, Quality Management System and the appropriate regulations for the area they support.
- Any other ad hoc projects as assigned.

Requirement:

- Minimum bachelor’s Degree in pharmacy, biomedical sciences or related studies. Fresh Degree Holder are welcome.
- Prior working experience in regulatory affairs function in the relevant industry is preferred.
- Good communication, negotiation and co-ordination skills are required to liaise with internal and external colleagues and service providers.
- Excellent planning and time management skills.
- Meticulous and attention for details.
- Be a team player, with excellent administration skills.
- Regulation knowledge on medical devices.
- Proactively seeks to develop and become well-versed within the regulatory landscape.
- Able to communicate and translate Technical documents from Chinese to English for relevant regulatory submission.

**Job Type**: Contract

Pay: RM4,000.00 - RM6,000.00 per month

Schedule:

- Monday to Friday

**Language**:

- Mandarin (required)

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