Regulatory Affairs Executive

4 weeks ago

Selangor, Malaysia Almedico Sdn Bhd Full time

**Purpose**
- To ensure that all product registrations are approved and ensuring the maintenance of these approvals by Medical Device Authority Malaysia.
- To respond efficiently for all field safety corrective action (FSCA) and product complaints / recall-related issues.
- To be in charge of maintaining the Goods Distributor Practices of Medical Devices (GDPMD) license and ISO 13485:2016 equivalent with Malaysia’s Ministry of Health.

**Responsibilities**
- Handling all regulatory compliance activities including medical devices registration, licensing, Free Sale Certificate, product change notification, studying scientific, medical device legal documentation and all regulatory documents by liaising closely with Medical Device Authority, Conformity Assessment Body, foreign embassies, notary public, Ministry of Foreign Affairs and any other governmental bodies.
- Ensure clients’ safety by liaising quickly with Medical Device Authority for all field safety corrective action (FSCA) and assist in handling of product complaints / recall-related issues.
- Responsible as a Quality Management Representative and member of Management Review Meeting for ISO 13485:2016 and GDPMD in company to monitor and assess quality systems by means of internal and external audits and other forms of evaluations against standards and local regulatory requirements.
- To update the ISO File and Infrastructure for both office and store.
- Liaise with overseas manufacturers / suppliers / partners pertaining to foreign regulatory affairs including the product registrations technical files, drawings, specs, label confirmations and audits of existing products and renewals.
- Keep close track of changes in the country’s regulatory requirements, changes, etc. and proactively implement effective and efficient regulatory strategies.
- To provide regulatory intelligence and support to the Company.
- To engage with the Conformity Assessment Body for product verification audits and help Company to find the most effective costs for product verification audit.
- To gather, evaluate, organise, manage and collate medical device technical file information in a variety of formats by referring to the Medical Device Authority Guideline
- Studying, understanding and maintaining familiarity with company product ranges.
- Keeping abreast with changes and updates in regulatory legislation and guidelines.
- Offering advice about Company policies, practices and systems.
- Outlining requirements for labelling, storage and packaging by referring to MDA guidelines
- Liaising and negotiating with regulatory authorities (KKM, MDA).
- Design and confirm the product labelling with the MD and suppliers.

**Required Knowledge, Skills and Abilities**
- Works under mínimal supervision.
- Good computer skills - at ease with usual programs (Word, Excel, etc) and proficient with statistics.
- Proficiency in both written and verbal English and Malay language and Mandarin will be an added asset/advantage.
- A positive, optimistic, and proactive mindset.
- Ability to handle sensitive and confidential information discreetly and professionally.
- Proficiency with practical knowledge in ISO 13485:2016 equivalent with Malaysia’s Ministry of Health. Effectively balances multiple priorities and project deliverables.
- Practice for Medical Devices (GDPMD).

**Minimum Required Education and Experience**

5+ years of experience with a Bachelor’s degree, or equivalent work experience, preferably in a scientific or technical discipline

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