Omron Healthcare Manufacturing ★ 1.5

The Senior Executive– Quality Assurance and Regulatory Affairs (QA/RA) provides support to the strategic leadership and will manage and monitor the activities related to all products and processes

Job Description:

1. Manage the process of product registration & market access approval proactively to allow “as early as possible” product registration including:

- All steps of regulatory approval process up to the market launch

- Registration during product lifetime until discontinuation

- The variation, licenses retention and post market regulatory management for business support

- Registration database maintenance to ensure accurate and up-to-date record filing

2. Manage necessary contacts with local authorities and organizations for regulatory compliance problem solving, obtaining updated information on current and developing regulations, product list clarification and launch timelines alignment.

3. All activities related to the QA/RA review, approval, escalation, impact-analysis, problem-solving and risk mitigating process of New Product Launch Process initiatives and manage the product design change. to existing products initiated by different parties like HQ, regional R, Business Partners or Authority Agencies

4. Remain up to date on regulations and communicate any key changes to stakeholders in the broader organization

5. Participate in and/or support various multi-functional teams and projects to ensure compliance to regulatory requirements for the designated sales areas, identify relevant guidance documents and standards, and assist teams with their interpretation and assist with determination of regulatory pathways for various projects including product classification and type of regulatory submission required.

6. Operationally manage and control the activities related to the development, maintenance, continuous improvement, simplification and compliance of Quality Management System(s).

- Serve as Management Representative/ Designated Person/ Qualified Personnel or Technical Person

- Create, review and approve the Standard Operating Procedures, Work Instruction and other quality documents cross-departmental.

- Lead and provide support during internal and external audits. Supervise, manage and close internal and external non-conformities

- Analyze and make recommendations regarding complaints received and whether they are reportable within the designated areas; participate in post-market surveillance activities as necessary.

7. Oversee the activities related to supplier management for quality management system including supplier registration, supplier evaluation and provide recommendation for improvements.

Job Requirements

- At least college degrees in engineering, medicine, pharmacy, chemistry, biology, or medical equipment engineering

- Experienced in the Medical Device industry.

- Possess adequate knowledge of business processes / procedures related to RA & Product Registration, regulatory frameworks and requirements in the designated country(s) for Medical Devices.

- Knowledge and understanding of national local regulations / requirements on regulatory approval / market access in accordance with applicable legislations will be highly advantageous but not mandatory

- Basic knowledge in regional and international Medical Device Regulation and/or medical device related (international) standards will be highly advantageous but not mandatory

- Demonstrated knowledge, application of audit principles and practices related to the Quality Management System under ISO 13485 or equivalent will be highly advantageous but not mandatory

- Proficient in English

- Good knowledge of MS Office

- Candidates with RA experience & willing to learn QA will also be considered

- Open to hire Executive/Senior Executive level, depending on experience