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  • jobs
  • 1 month ago

jobs description

Are you an experienced Regulatory Affairs professional who thrives in a fast-paced environment?

Do you have a passion for building and implementing Regulatory Affairs strategy?

Are you based in the Netherlands or Germany?

Fraser Dove International is working with a leading Medical Device company at who are extremely ambitious. They are now at an exciting stage of growth and are looking to increase their headcount to accommodate this. The culture within the organization is lean, fast-paced and collaborative.

As the Regulatory Affairs Director, you will be responsible for developing and implementing regulatory strategy and lead the health authority submissions and life-cycle management of unique products to serve patients with unmet medical needs.

Discover more about our Regulatory Affairs Director opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Director Regulatory Affairs, you will be... measured against the following objectives:

1) Provide Regulatory strategic leadership

Be the lead for health authority interactions, regulatory submissions and other activities.

2) Subject Matter Expert in Regulatory

Lead meetings and preparations with the EMEA region and other health authorities to facilitate approval.

3) Be hands-on and work collaboratively across multiple functions

Provide support to the regulatory team and push the sense of urgency for regulatory affairs throughout cross-functional teams.

What you will do:

As the Regulatory Affairs Director your duties and responsibilities will include:
• Develop and implement the Regulatory Affairs strategy.
• Manage and lead health authority meetings, preparations and submissions.
• Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations.
• Contribute to the strategic leadership and development of policies, procedures and best practices.
• Provide support to EU Medical Device Regulations, MDCG Guidance, UK and Switzerland regulations, Saudi Arabia regulations, and other international requirements. Must be able to lead the preparations and submissions of product approvals and submissions, which includes CE marking Technical Files within EMEA to gain market entry into specific countries.
• Serve as a subject matter expert on Regulatory Affairs for the organization.
• Provide de-risking development strategies and evaluating opportunities to accelerate development.

What you will bring:

These are the skills and experience you will need to succeed as Regulatory Director:
• Strong knowledge of EMEA regulations.
• Proven experience and success with filing within Medical Devices.
• Experienced in setting strategies and preparing regulatory documents.
• FDA and other health authority interaction experience.
• Experience with biologics drug development at early and late-stage is desirable.

What you will get:

These are the perks and benefits that will complement your generous base salary:
• Performance Bonus
• Stock Options
• Private Pension

NB

Due to high volumes of applications, If you have not heard from a Consultant within 10 working days from the date of your application, please consider yourself unsuccessful on this occasion. Remember to keep checking our job ads on LinkedIn for future opportunities.

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Netherlands

salary-criteria

Apply - Director of Regulatory Affairs EMEA Netherlands