Regulatory Director - Medical device

Regulatory Affairs Director

Are you looking to take a step up? have you worked with medical device regulatory affairs in a line manager function and want to set up to a be in charge of a global team? Do you want to be a key player in a major organization? then I got the challenge for you

I am looking for a regulatory director for a Large and growing medical device company working with class1-3 products

You will lead an international team of around 15 employees and have 2 line managers reporting to you and you will be the go-to person for various parts of the organization every day and have a key role in multiple global activities and projects, so if you are looking for that next step up to become the leader of leaders in a regulatory setting, then this is your chance.

expected located in Malmö, Sweden.

travel is required, approx. 20 %.

the position

• Regulatory Product Compliance and managing company-wide regulatory projects.
• Maintaining and developing the company regulatory processes and systems compliant across sites with requirements of notified bodies, competent authorities as FDA, Health Canada, TGA, MHLW, ANVISA, and other relevant regulatory requirements.
• Providing regulatory support, advice and communications to the various functions in the company.
• Ensuring effective communication to management regarding new standards, regulations and initiatives that could impact company products and quality management processes.
• Regulatory support to Design and Development functions and projects by managing the development and implementation of regulatory strategies for new and modified medical devices leading to new product submissions and product regulatory approvals.
• Ensuring establishment registrations, device listings and product registrations worldwide.
• Communication with regulatory authorities and promoting a strong working relationship with agencies, notified bodies and organizations.
• Participating in and support coordination and management of third-party audits and regulatory inspections.
• Ensuring monitoring, impact assessment and implementation of standards and regulations applicable to the company's products.

requirement

• A Master's degree within engineering, natural sciences or similar
• experience with introducing products to new markets
• previous leadership experience, prefered leader of leaders
• Experience with CE marking, FDA
• experience and knowledge of the global regulatory landscape in e.g. China, Japan, Brazil and Korea.

If you are interested, then get in touch with, Casper Skyum Hogh by applying below.
You can also connect with me on LinkedIn and send your Cv to me in a word format on the email found on my profile or find more opportunities that we have available on Nonstop's website

I am a specialised recruiter within Regulatory affairs and medical affairs in the Pharma, Biotech and Medical Device industry. I, therefore, have access to an extensive network within these industries, which aren't available otherwise. If the above opportunity doesn't have your interest, but you would like to hear more about potential opportunities, then you are welcome to contact me for a noncommittal, confidential chat.

If you know someone in your network who may be interested in the above, then you are more than welcome to pass on my details to them, so that I can be of assistance to them.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic, and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.