A leading Medical device company is hiring Regulatory Affairs Specialist ✍️

Responsibilities:

✅ Support and implement product regulatory plans, provide guidance on global regulatory and product registrations for medical device.

✅ Preparation and registrations regulatory submissions and compile submissions in USA, Canada and Europe, or other required documents for Competent Authorities.

✅ Create and maintain Technical File/Documentation product file SW's requirements

✅ Follows up of mandatory requirements for registration: local certificates

✅ Communicates information and presents status updates on product/project activities to key internal/external when requested.

✅ Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.

✅ Practice on pFMEA, V&V IQPQOQ in production process.

Requirements:

✅ Understanding the Quality medical device system (ISO 13485) and medical device regulations.

✅ Bachelor’s degree or country equivalent in Engineering or Science or related scientific discipline, or equivalent.

✅ Key Attributes (Experience, skills and technical knowledge)

✅ Minimum of 5 years regulatory or equivalent experience within medical device company, or similar organization.

✅ Excellent English written and Verbal communication skills.

✅ Proactive, high performance, result oriented and manage projects With ethical integrity.

✅ Technical system skills (e.g. MS office applications, databases.

✅ Efficient online research.

Manage multiple projects and deadlines

The job involves traveling in Israel and abroad

The company is located in Jerusalem

Are you up for the challenge?

Please send your CV to jobs@d-hr.co.il specify JB-251