Regulatory and operations manager

About the Company:

Voyager Medical Research is an innovative and growing startup in the medical device sector focused on cutting-edge solutions in biodegradable medical polymers for surgical application. We are seeking a highly motivated Regulatory and Operations Manager with a strong background in both regulatory affairs and operations management. This is a unique opportunity to contribute to a dynamic, fast-paced company and play a key role in driving our product from development to market launch in the U.S. and Europe.

Key Responsibilities:

Regulatory Affairs:

- Lead the regulatory strategy and submission process for medical devices, focusing on approvals in the U.S. (FDA) and Europe (CE marking).

- Prepare and manage regulatory documents, ensuring compliance with applicable standards (e.g., ISO 13485, MDR 2017/745).

- Liaise with regulatory agencies, maintaining active communication to facilitate successful product approvals.

- Conduct risk assessments and gap analyses for new and existing products, providing strategic recommendations.

- Stay up-to-date with regulatory changes and guidelines in the medical device industry, particularly in medical polymers.

Operations Management:

- Oversee daily operational activities, ensuring efficient production and supply chain processes.

- Collaborate with R&D, quality assurance, and manufacturing teams to ensure seamless product development and launch.

- Implement and manage operational policies, procedures, and best practices to optimize workflow and resource allocation.

- Coordinate with vendors, suppliers, and manufacturing partners to meet project timelines and quality standards.

- Monitor key performance indicators (KPIs) and provide regular reports on operational performance to senior management.

Qualifications:

Experience:

 - Minimum of 5 years of experience in regulatory affairs for medical devices, with a proven track record of obtaining product approvals in the U.S. (FDA) and Europe (CE marking).

 - Minimum of 5 years of experience in operations management, ideally within a startup environment in the medical device industry.

 - Experience in the field of medical polymers is highly desirable.

Education:

 - Bachelor’s degree in a relevant field such as Biomedical Engineering, Regulatory Affairs, Medical Device Management, or Life Sciences.

 - Advanced degree (e.g., Master’s in Regulatory Affairs, MBA with a focus on Healthcare Management, or Master’s in Biomedical Engineering) is preferred.

Skills and Competencies:

 - In-depth knowledge of FDA regulations, European MDR, and ISO standards (e.g., ISO 13485).

 - Strong project management skills, with experience handling multiple projects and priorities simultaneously.

 - Excellent written and verbal communication skills, with the ability to interact effectively with internal teams, regulatory bodies, and external stakeholders.

 - Demonstrated problem-solving skills and the ability to adapt to the challenges of a startup environment.

 - Proficient in using software tools for regulatory submissions, project management, and operational analysis.

- Fluent english – written and verbal.

This position is only offered to candidates residing in Israel.

What We Offer:

- Competitive salary and options package

- Opportunity to make a significant impact in a growing company

- Opportunity to work remotely in full.

To Apply:

Please submit your resume and a cover letter detailing your experience and why you are a great fit for this role to [email protected]

• This role requires strong expertise in both regulatory affairs and operations management, as well as experience working in a startup environment with medical devices, particularly in medical polymers. If you are a results-driven professional looking for a challenging and rewarding role, we would love to hear from you!