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 Regulatory Affairs Specialist for an International Medical Device company to join our team.

Location: Yoqneam, Israel

Key Responsibilities:

• Develop and maintain international documentation to support product registration and changes.
• Collaborate with Regulatory Affairs core team members to create detailed Regulatory Plans.
• Coordinate the submission of Regulatory documents to worldwide regulatory agencies.
• Prepare responses to regulatory correspondence on a global scale.
• Review and approve new product development and product modification documentation.
• Manage Regulatory Affairs electronic communication tools, including SharePoint, international databases, and request tracking systems.
• Write, review, and revise company Standard Operating Procedures (SOPs) as required.
• Participate in RA Company Compliance initiatives.

General Duties:

• Communicate business-related issues or opportunities to the next management level.
• Prepare for internal and external audits.
• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in Engineering, Physical Sciences, or Biological Sciences (Preferred).
• 2-4 years of experience in Regulatory Affairs.
• Ability to work independently and collaboratively within a team.
• Strong problem-solving skills and the ability to identify and implement solutions for process gaps.

Required Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

• Knowledge of FDA Regulations and/or CE Marking Requirements.
• Excellent communication skills, both verbal and written.
• Strong organizational and project management skills.
• Effective problem-solving abilities.
• Proficient in presentation skills.
• Familiarity with MS Office applications, SAP, COGNOS, and SharePoint.