Global Regulatory Affairs Manager
Vor 6 Tagen
Job Title: Global Regulatory Affairs Manager
Job Type: Full-time
Company: Elemed
Location: Remote
About Us: Elemed is a leading MedTech technical recruiter specializing in the Medical device, diagnostic, and combination device arena. We help medical device experts become leaders of tomorrow.
Job Summary: We are seeking an experienced Global Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for enabling and navigating product launches in various markets globally, with a focus on international markets.
Key Responsibilities:
- Stay up-to-date with the latest regulatory developments in key global markets (Asia-Pacific, North America, and the EU)
- Identify, review, advise, and present plans of action to internal teams globally on the latest regulatory changes in the market and their wider impact on market access and product compliance
- Be the 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 in governmental and external agency audits and take pre-audit and post-audit actions
- Create internal and external reports for the global headquarters
Requirements:
- At least 12 years' experience in Regulatory Affairs with a Medical Devices Manufacturer
- Experience within the medical device industry is required
- Fluent written and spoken English
- Eligible to live and work in the European Union, UK, Switzerland, or EEA
What We Offer:
- A rare and great opportunity to join a globally leading manufacturer in active implantable devices for liver treatments
- A company-critical role with a key focus on international markets
- A chance to influence internal teams across different functions to help them understand regulatory expectations and introduce new processes
- A role that requires leadership and guidance of other members of the RA team
- A chance to participate in governmental and external agency audits
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