Manager Global Regulatory Affairs

Title : Global Regulatory Affairs Manager

Location : Remote

Contact : [email protected]

The company

Are you someone who has Medical Device market-access experiences globally beyond Europe? Do you have Global Medical Device Product Launch experiences particularly in China, or Japan, or the USA, or Central Asia?

Are you looking for the next step in your career in the medical devices industry where your work is visible by multiple departments at the Headquarters?

Do you see yourself joining an established, international company where there is investment into RA and QA?

If yes, here is a rare and great opportunity to join a globally leading manufacturer in active implantable devices for liver treatments.

As the Global Regulatory Affairs Manager, you will be reporting directly to their global headquarters in Europe and work in a global team environment.

This is a company-critical role and your past experiences in Medical Device Regulatory Affairs will be key to help this manager and the global project teams to navigate challenging market-access or remediation projects in multiple countries and regions of the world.

You will be responsible for enabling and navigating product launches in various markets globally, with a key focus in international markets.

Furthermore, you will be responsible for influencing internal teams across different functions to help them understand what the authorities in these key markets typically expect, what are the new regulations, introduce new processes, and assist the HQ with more efficient Regulatory Affairs processes.

In this role you will report directly to the Global Head for Regulatory Affairs at the global headquarters in Europe.

Your responsibilities :

As the Global Regulatory Affairs Manager you will :

• Keep yourself and your colleagues up-to-date with latest regulatory developments in key global markets (Asia-Pacific, North America, and the EU)
• Identify, review, advise and present plan of action to internal teams globally of the latest regulatory changes in the market and their wider impact on market access, product compliance
• Key point-of-contact for the company’s internal database of regulatory information
• Show leadership by guiding other members of the RA team on different processes in different regions
• Participate (and sometimes negotiate) in governmental and external agency audits and take pre-audit and post-audit actions
• Create internal and external reports for the global headquarters.

Your qualifications :

For this Global Regulatory Affairs Manager, you will bring :

• At least 12 years’ experience in Regulatory Affairs with a Medical Devices Manufacturer
• Experience within the medical device industry is required
• Fluent written & spoken in English
• Eligible to live and work in the European Union, UK, Switzerland, or EEA

If you are interested in this exciting role, please send your application directly to [email protected]

Would you like to find out more about our open opportunities? Visit https : / / www.elemed.eu / vacancies /

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.

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.

We won Best International Recruitment Agency at the Recruiter Awards 2021.

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.

Learn and develop as a regulatory, quality or clinical professional with 1 : 1 mentorship from a highly experienced mentor.

Our mentors are some of the most inspirational and talented senior professionals in the medical device and IVD industry.

We handpick your mentor and make the match based on your mentoring goals and their experience. Learn more >

https : / / www.elemed.eu / elemedsmentoringacademy20 /

Join hundreds of fellow regulatory, quality and clinical professionals in Elemed’s RQC Network. Find the answers to 1000+ industry-related questions (including topics such as MDR, IVDR, PRRC, certification, validation and more), attend expert-led masterclasses and more. Learn more here >

https : / / www.rqc.network /

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.