Regulatory Affairs Assistant

2 weeks ago

Chennai, India Ovesco Endoscopy India Private Limited Full time

**Regulatory Affairs**

**This is us**:
Ovesco Endoscopy is a research-based medical device company specializing in flexible endoscopy.

We develop, produce, and sell highly innovative instruments and systems for the treatment of gastrointestinal diseases. We offer comprehensive procedures and accompany our customers all the way from training to intervention.

**This is you**:

- Bachelor’s degree in life science / engineering fields / advanced degree preferred
- At least 3 years of professional experience in international regulatory affairs for medical devices or pharmaceuticals
- Very good written and spoken English skills, further foreign language skills such as German would be an advantage
- Sound understanding of registration of Medical Device (Import) in India
- Knowledge about Indian Regulatory Guidelines
- Experience on regulatory submissions required
- Experience with regulatory affairs in highly regulated markets (e.g.

USA, Japan) desirable
- Experience with regulatory affairs in the Asian and Middle East advantageous
- Independent and structured way of working
- Interest in innovative medical devices

**This awaits you**:

- Independent processing and maintenance of international product approvals
- Annual approval planning in cooperation with the regional sales managers and the Head of Quality Management & Regulatory

Affairs including review appointments during the year
- Communication with authorities, notified bodies and approval service providers as well as provision of documents and records from the technical product documentation and the quality management system within the scope of international product approvals
- Preparation, review and approval of elements of the technical product documentation as well as documents of the quality management system
- Continuous improvement of the organization of approval-relevant documents in cooperation with the technical documentaries

**What we offer**:

- Exciting opportunity in a **Short decision-making fast-growing company in processes and flat hierarchies the field of medical devices ** Responsible and exciting tasks
- Challenging multifaceted in a highly motivated team job in an international
- Great flexibility in managing environment daily tasks
- Long-term development opportunities **Good working atmosphere**:
**Interest awakened?**

Ability to commute/relocate:

- Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 3 years (required)

Application Deadline: 04/04/2023
Expected Start Date: 15/04/2023

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