Director Regulatory Affairs

?? Title: Director Regulatory Affairs, USA
?? Location: Work from home, East Coast, USA
?? Contact:

?? The Company

Join a well established, commercial stage company designing, developing and producing an innovative Class III active implantable medical device that changes the lives of patients. The device is CE marked, and preparing to submit for US approval.

With a strong KOL network in Europe and North America the company is looking for a hands-on Director Regulatory Affairs to represent and support the company with its US regulatory strategy and be the operational main point of contact with the US FDA.

This is a great opportunity to work on an AIMD that has no predicate (making it unique and challenging!), have great exposure to the senior leadership team (you will report to the VP Quality / Regulatory, and to be part of a company's growth story.

If you are looking for a Director role with a large team to manage, this position is not for you. This role is all about being hands on with the product and working closely with your global counterparts in Europe (Switzerland), where everyone is working towards the same goal.

In this role you'll be a trusted advisor to the VP QA/RA and leadership team and the operational POC with the US FDA. If you're looking for a role that gives you flexibility and autonomy to use your US FDA experience in a new context, this is one for you! You'll enjoy a wide variety of responsibilities covering both pre- and post-market activities for the USA, for the company's existing portfolio, changes and supplements.

?? As Regulatory Affairs Director USA you'll report to the Global VP of QA/RA.
Your responsibilities will cover:

• One region (the USA) - all products, systems and regulatory activities. You'll be interfacing heavily with the Global Director of Regulatory and Compliance and working in partnership with the global QA/RA team in Europe (Switzerland)
• You'll operationally represent the company as the operational lead for all pre- and post market activities specifically for the United States.
• Your goal: to get product approvals. You'll be supporting pre-market submissions (PMA's) and be responsible for post-market supplements to the FDA, ensuring timely renewals and registrations for the US in accordance with FDA timelines.
• You'll evaluate the impact and implication of process and design changes on US regulatory compliance and whether there is need for submission
• You'll support the communication with the FDA through activities such as; regulatory correspondence, supporting the formulation of responses to deficiency letters, supporting 3rd party external audits/ FDA inspections, etc.
• As the company's expert for the US, you'll provide US input and perspective on the strategies that are developed for US regulatory approvals
• Support the review of promotional materials intended for the US and and formulate product labeling for new products
• Ensure that the DHF/DMR for the US is kept up to date

?? Requirements:

• 8+ years experience with new product introductions/ supplements in the US market for medical devices
• Experience with the evaluation of process and design changes and their impact on FDA requirements/ existing approvals / need for submission
• Experience with active medical devices
• Hands on and strategic thinker. Desire to be close to the product and activities.

?? If you are interested in this exciting role, please send your application directly to

?? Would you like to find out more about our open opportunities? Visit

Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.
Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.
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?? Elemed is Europe's leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.

At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.

?? We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.