Competences:

- B.Pharm / M.Pharm with 2-5 years experience in Regulatory Affairs with Medical Device / Medical Consumable / Pharmaceutical Companies

- Regulatory knowledge in handling pharmaceutical products as well as medical devices.

- Experience of preparation and submission of CTD in different countries for ROW market.

- Experience in handling queries received from NDRA in compliance to regulatory requirement.

- Experience in handling variations.

- Updated on various regulatory guidelines on WHO, EU and ICH.

- Should be energetic and passionate about work.

- Ability to maintain positive attitude when under pressure and in stressful situations.

- Good administrative skills.

- Experience in project management.

- Team player with good communication skills.

- Should be well structured and systematic.

- Regulatory experience in medical device industry (EU MDD/MDR, USFDA, Health Canada, IMDRF) or equivalent experience in a related field.

- Knowledge of Medical device quality management system (ISO 13485), Risk management (14971) would be added advantage.

Duties/Responsibilities:

- Responsible for coordination with supplier for arranging documents timely for dossier compilation.

- Concurrent follow-up with Country Manager, Agent and NDRA for ongoing submissions.

- Responsible for preparation, review and dispatch of registration dossiers for pharmaceutical products and medical devices as per application country guidelines.

- Preparation of technical files for CE marking based on branded and generic medical devices.

- Responsible for samples dispatch and to provide information to CM and agents.

- Review of registration dossiers (incl. SPC and leaflets).

- Ensure all activities related to Regulatory Affairs (RA) complies with Company's SOPs and regulatory / customer requirements.

- Responsible for evaluation, response preparation with supporting documents from supplier to query received from NDRA within deadlines.

- Coordination with cross-functional dept. on regulatory assistance

- Review of product layouts (labels, leaflets, SPCs) in line with regulatory guidelines pharmaceutical products and medical devices.

- Proactive and dedicated work on product registration ensuring meeting deadlines.

- To support activities within team and collaborate on the development of strategies, execution of projects and ad hoc tasks.