Lee Hecht Harrison Nederland B.V.
Regulatory Affairs Specialist
Lee Hecht Harrison Nederland B.V., Carlsbad, California, United States, 92002
Regulatory Affairs Specialist - Remote Opportunity
LHH, in partnership with a leading medical device company, is looking for experienced Regulatory Affairs Specialists to join the team. This fully remote position offers the chance to work on exciting projects in the medical device field.
Key Responsibilities:Ensure compliance with international regulations, especially the European Union’s standards.Handle documentation and notifications for regulatory bodies and international customers.Submit change notifications to multiple Notified Bodies, EU Authorized Representatives, international Authorized Representatives, and international Distributors.Update Technical Documentation for address and manufacturing changes of two legal entities.Work cross-functionally to detail manufacturing and address changes.Track and follow up on communication with all international Distributors and Authorized Representatives.Update international licenses as required by international Distributors and Authorized Representatives.Review and approve Change Orders regarding manufacturing and address changes.Represent Regulatory Affairs in project meetings.Update clinical, post-market, and summary of technical documentation, and input new documents from cross-functional teams into Technical Documentation.Submit Label Checklists to the labeling team.Reserve and apply new UDI for address and manufacturing changes.Communicate changes with all State License bodies.
Must-Haves:At least three years of experience in regulatory affairs within the medical device industry.Proven track record of working with international regulations, especially within the EU.Familiarity with project management tools is a plus.Experience registering medical devices internationally and in the EU.Understanding of FDA regulations for medical devices.Experience creating technical documentation for medical devices.Preferred experience with state licensing bodies.Comfortable using Office 365 (Outlook, Word, Excel; Access is a bonus).Able to work independently and as part of a team.Self-motivated and productive with minimal supervision.
Schedule:40 hours per week, Monday to Friday, 8:00 AM - 4:30 PM.Position Type:Temporary position, 6 months with potential for extension.Pay Details:
$20.00 to $23.00 per hourEqual Opportunity Employer/Veterans/Disabled
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LHH, in partnership with a leading medical device company, is looking for experienced Regulatory Affairs Specialists to join the team. This fully remote position offers the chance to work on exciting projects in the medical device field.
Key Responsibilities:Ensure compliance with international regulations, especially the European Union’s standards.Handle documentation and notifications for regulatory bodies and international customers.Submit change notifications to multiple Notified Bodies, EU Authorized Representatives, international Authorized Representatives, and international Distributors.Update Technical Documentation for address and manufacturing changes of two legal entities.Work cross-functionally to detail manufacturing and address changes.Track and follow up on communication with all international Distributors and Authorized Representatives.Update international licenses as required by international Distributors and Authorized Representatives.Review and approve Change Orders regarding manufacturing and address changes.Represent Regulatory Affairs in project meetings.Update clinical, post-market, and summary of technical documentation, and input new documents from cross-functional teams into Technical Documentation.Submit Label Checklists to the labeling team.Reserve and apply new UDI for address and manufacturing changes.Communicate changes with all State License bodies.
Must-Haves:At least three years of experience in regulatory affairs within the medical device industry.Proven track record of working with international regulations, especially within the EU.Familiarity with project management tools is a plus.Experience registering medical devices internationally and in the EU.Understanding of FDA regulations for medical devices.Experience creating technical documentation for medical devices.Preferred experience with state licensing bodies.Comfortable using Office 365 (Outlook, Word, Excel; Access is a bonus).Able to work independently and as part of a team.Self-motivated and productive with minimal supervision.
Schedule:40 hours per week, Monday to Friday, 8:00 AM - 4:30 PM.Position Type:Temporary position, 6 months with potential for extension.Pay Details:
$20.00 to $23.00 per hourEqual Opportunity Employer/Veterans/Disabled
#J-18808-Ljbffr