Regulatory Affairs Manager

**Position**: Regulatory Affair Manager

**Industry**: Healthcare/ Medical Device

**Responsibilities**
- Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
- Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
- Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
- Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
- Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
- Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
- Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
- Ensure compliance with advertisement and labeling regulations in each marketing territory.
- Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
- Plan and lead the implementation of internal RA audits on an annual basis.
- Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
- Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
- Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
- Support regulatory matters related to custom import requirements and documentation.
- Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.

**Qualifications**
- Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.

**Required Skills**:

- Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
- Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers, effectively.
- In-depth knowledge and **hands-on experience in medical device registration and regulatory compliance**, particularly in Malaysia, Singapore, and Indonesia.
- Solid **understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.**:

- Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
- Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
- Meticulous and detail-oriented, capable of working independently with mínimal supervision.
- Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
- Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
- Pharmacist background with a valid license will be an added

**Job Type**: Permanent

Pay: RM6,000.00 - RM9,000.00 per month

**Benefits**:

- Flexible schedule
- Free parking
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development
- Work from home

Application Question(s):

- How many years of experiences working in healthcare or Medical Device Industry ?
- How many years experiences working with ISO 13485 and GDPMD?
- Experience in medical devices registration?
- Has hand on experiences working with regulatory authorities ?

**Education**:

- Bachelor's (preferred)

Work Location: In person