Lee Hecht Harrison Nederland B.V.
Regulatory Affairs Specialist (Remote)
Lee Hecht Harrison Nederland B.V., San Diego, California, United States, 92189
Regulatory Affairs Specialist (Remote)
LHH has partnered with a Medical Device company that is seeking a skilled Regulatory Affairs Specialist to assist their team! This temporary role involves managing regulatory submissions and updates for multiple entities and coordinating with international partners. This position can be worked
100% remote.
Key Responsibilities:Submit change notifications to Notified Bodies, EU Authorized Representatives, international Authorized Representatives, and distributors.Review and approve change orders related to manufacturing and address updates.Update technical documentation for address and manufacturing changes.Track and follow up on communications with international distributors and Authorized Representatives.Update clinical, post-market, and technical documentation.Manage label checklists and apply new Unique Device Identifiers (UDI) as needed.Communicate with state licensing bodies regarding changes.Requirements:2+ years of experience in regulatory affairs within the medical device industry.Experience with technical documentation and registering medical devices.Proficiency in Office 365 (Outlook, Word, Excel; Access is a plus).Ability to work independently with minimal supervision.Strong organizational skills and a proactive approach to managing tasks.Additional Details:Location:
Fully RemoteDuration:
6+ monthsHours:
Monday-Friday, 8 AM - 4:30 PM (local time zone)Pay:
$21-$23 per hour
If you are a motivated, detail-oriented professional with a strong regulatory background and a passion for the medical device industry, we encourage you to apply!
#J-18808-Ljbffr
LHH has partnered with a Medical Device company that is seeking a skilled Regulatory Affairs Specialist to assist their team! This temporary role involves managing regulatory submissions and updates for multiple entities and coordinating with international partners. This position can be worked
100% remote.
Key Responsibilities:Submit change notifications to Notified Bodies, EU Authorized Representatives, international Authorized Representatives, and distributors.Review and approve change orders related to manufacturing and address updates.Update technical documentation for address and manufacturing changes.Track and follow up on communications with international distributors and Authorized Representatives.Update clinical, post-market, and technical documentation.Manage label checklists and apply new Unique Device Identifiers (UDI) as needed.Communicate with state licensing bodies regarding changes.Requirements:2+ years of experience in regulatory affairs within the medical device industry.Experience with technical documentation and registering medical devices.Proficiency in Office 365 (Outlook, Word, Excel; Access is a plus).Ability to work independently with minimal supervision.Strong organizational skills and a proactive approach to managing tasks.Additional Details:Location:
Fully RemoteDuration:
6+ monthsHours:
Monday-Friday, 8 AM - 4:30 PM (local time zone)Pay:
$21-$23 per hour
If you are a motivated, detail-oriented professional with a strong regulatory background and a passion for the medical device industry, we encourage you to apply!
#J-18808-Ljbffr