Global Regulatory Affairs Manager
vor 1 Woche
Job Title: Global Regulatory Affairs Manager
Job Summary:
We are seeking an experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for medical devices in various global markets.
Key Responsibilities:
- Stay up-to-date with the latest regulatory developments in key global markets, including 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.
- Act as the key point-of-contact for our internal database of regulatory information.
- Provide leadership and guidance to other members of the RA team on different processes in various regions.
- Participate in governmental and external agency audits and take pre-audit and post-audit actions.
- Create internal and external reports for our 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.
About Elemed:
We are a leading MedTech technical recruiter specializing in the Medical device, diagnostic, and combination device arena. Our team helps medical device experts become leaders of tomorrow.
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.
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