Regulatory Compliance Specialist

Overview

*This is an NBN Connect post on behalf of another organization.

The Regulatory Compliance Officer will support the development and implementation of regulatory strategies to ensure that the company’s products, services, and processes comply with applicable laws, regulations, and standards, particularly those set by the FDA (Food and Drug Administration). This role involves assisting with regulatory submissions, maintaining documentation, and ensuring ongoing compliance with industry rules and regulations.

We are a fast-growing global medical device company dedicated to advancing healthcare through innovative technology. Our team spans across Israel, the United States, and the UK, and we are committed to improving patient outcomes worldwide. As we grow, we are seeking a dynamic Regulatory Compliance Officer to join our team and contribute to our mission.

Key Responsibilities:

• Regulatory Support:
• Assist in preparing, reviewing, and submitting regulatory filings.
• Maintain regulatory documentation for medical devices to ensure compliance with FDA and other regulations.
• Monitor changes in regulations, standards, and guidelines.
• Quality Systems & Compliance:
• Assist in conducting internal audits and ensure audit readiness.
• Help ensure compliance with post-market surveillance activities
• Cross-Functional Collaboration:
• Collaborate with logistics, sales and clinical teams to gather data required for regulatory submissions and audits.
• Provide regulatory guidance during product development, manufacturing, testing and delivery to ensure compliance with FDA and other applicable standards.
• identify potential compliance risks and develop strategies to meet all policies.
• Act as a key point of contact for regulatory documentation requests and support during external audits or inspections.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
• 4-5+ years of experience in regulatory affairs, preferably in the medical device or healthcare industry.
• Strong organizational skills with an ability to manage regulatory documents and submissions.
• Strong organizational skills and attention to detail.
• Excellent communication skills in English, both written and verbal.
• Ability to work effectively in a fast-paced, multi-cultural environment.