Regulatory Affairs Specialist

HanDyMann is a leading boutique company in the field of Engineering Services located in Yoqneam, Jezreel Valley. We provide a wide range of engineering capabilities: components engineering, technical documentation for the medical device industry, V&V, QA & QC, building engineering infrastructure, project management, NPI, and more.

Working with us will provide you great success following the training program the company provides to its employees a place where they can stand out and express their abilities.

We are looking for a Medical Affairs Specialist for an International Medical Device company Located in Yoqneam (North Israel).

As a Medical Affairs Specialist you will be responsible for EU, Israel, and China registration,

you will play a pivotal role in ensuring the successful registration and compliance of our medical products in these regions.

This position requires a meticulous understanding of regulatory requirements and a proactive approach to maintain and update technical documentation.

Your primary responsibilities will include assessing product changes, maintaining and submitting technical documents, and providing essential support to the local teams in the registration processes of our medical products in Israel and China.

You will also:

Prepare international documentation to support product registration and changes

internationally.

Works with RA core team members to develop the creation of detailed Regulatory

Plans.

Coordinates the submission of Regulatory documents to regulatory Agencies.

Prepares responses to Regulatory correspondence

Review and approval of new product development and product modification

documentation.

Maintain Regulatory Affairs electronic communications tools, including SharePoint

site, international databases and request tracking systems, and electronic libraries.

Write, review and revise company SOPs as required.

Participates in RA Company Compliance

REQUIRED KNOWLEDGE & SKILLS

Bachelor’s degree. Preferred in Engineering, Physical or Biological science.

2 – 4 years of experience in Regulatory Affairs.

Ability to work both independently and in a team environment. Ability to problem solve,

recognize, and find solutions for gaps in processes

• Knowledge of FDA Regulations and/or CE Marking Requirements

• Excellent communication skills (verbal and written)

• Strong organizational skills

• Project management skills

• Problem solving skills

• Presentation skills

• Must be familiar with MS Office applications, SAP, COGNOS and SharePoint