Medical Affairs Senior Associate

4 days ago

Singapore Bioptimal International Pte Ltd Full time

We are a global leader in manufacturing of medical devices and deliver solutions to improve lives through today’s technology and future innovation. Due to business needs, we are now seeking for multiple experienced Regulatory Affairs executives to be part of our Regulatory Affairs team for ongoing transformation projects due to expansion.

**Medical Affairs, Senior Associate**
- Provide Regulatory requirement guide to internal teams for countries submission.
- Work closely with regional sales team and distributors to drive new registration / license renewal activities in Europe and American.
- Market research of regulatory requirements and changes and provision of regulatory advice to internal team. Provide regulatory support to R&D team in strategic planning, pre-marketing, and related submissions to support optimal timelines for new and changed product launches.
- Understand the context of EN ISO13485, MDR, FDA 21 CFR Part 820
- Interface with Singapore QARA and Engineering and R&D Teams to define product profile and successfully translate into clinical development
- Manage the clinical aspects (E.g. Clinical evaluation, Post market clinical follow up, Post market surveillances, etc)
- Perform literature search, filter, summarize and compile into relevant documents to support MDR registration and serve as a part of the technical files.
- Perform write-up and state-of-the art discussions, update CER in a timely manner.
- Plan, develop and implement the development of clinical strategies and plans to integrate our project pipeline into standard practice according to MDR.
- Involve with product complaint investigation and follow up with the clinical follow up
- Oversee the analysis and interpretation of clinical trial data or PMS data
- Identify the regulatory trend related to clinical aspects and ensure the regulatory activities is compliance with our internal SOP.
- Provide support and work with Medical board to develop and communicate the overall clinical strategy.

**Requirements**:

- Degree in medical or life science with 5 years medical devices related operation or medical writing experience or at least 10 years of experience in Regulatory Affairs in medical device industry
- Must be scientific and data-driven
- Experience in Problem Solving
- Good English writing skill
- Experience in SCI publication is preferable
- Board scientific, technical and regulatory understanding of most of the functions involved in the development of a CCP product.
- Excellent Interpersonal and communication skill and possess positive attributes
- High level of integrity and able to work under stress and deliver work as per schedules
- Self-starter and independent
- Able to recommend critical decisions with calculated and justifiable risk through analytical thinking

**To apply**:

- Work experiences and job responsibilities
- Current and Expected salary
- Reason for leaving
- Date of availability
- Education background

**Job Types**: Full-time, Permanent

Pay: $4,000.00 - $8,000.00 per month

**Benefits**:

- Dental insurance
- Food provided
- Free parking
- Health insurance

Schedule:

- Monday to Friday

**Experience**:

- Regulatory Affairs: 5 years (preferred)
- Medical Devices Industry: 5 years (preferred)

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