Lee Hecht Harrison Nederland B.V.
Regulatory Affairs Specialist
Lee Hecht Harrison Nederland B.V., San Diego, California, United States, 92189
LHH Recruitment Solutions is seeking a highly skilled Regulatory Affairs Specialist with expertise in the medical device industry for a minimum 6-month contract role. As part of a Fortune 500 company, you will play a crucial role in ensuring regulatory compliance and supporting product development within the medical equipment manufacturing sector. This fully remote position offers the flexibility to work from anywhere and requires experience in the medical device industry.
Key Responsibilities:
Prepare and submit regulatory documentation to relevant authorities (e.g., FDA, EU MDR) for medical devices
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure products meet global regulatory requirements
Track and manage communication with all international Distributors, Authorized Representatives, and State License bodies
Monitor and interpret regulatory changes, providing guidance to internal teams
Submit change notifications to multiple Notified Bodies and EU Authorized Representatives
Maintain regulatory files and documentation in compliance with company policies and industry standards
Support post-market surveillance activities, including adverse event reporting and product labeling updates
Submit Label Checklists to the labeling team
Review and approve Change Orders related to manufacturing and address changes
Qualifications:
High school diploma or equivalent
Minimum of 1 year of experience in regulatory affairs within the medical device industry is required
Strong understanding of global regulatory requirements
Excellent communication and organizational skills
Comfortable using Microsoft Office Suite
Working Hours:
40 hours per week
Full-time
Remote
Monday- Friday
8:00 am - 4:30 pm
Details:
6-month contract role
Located in Carlsbad, San Diego, CA
Compensation: $20.00 - $22.00 per hour DOE
If you have the qualifications above and are interested in this opportunity, then please apply now. We are conducting interviews as soon as possible!
Pay Details:
$20.00 to $22.00 per hour
Search managed by:
Ciara NortonBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance
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Key Responsibilities:
Prepare and submit regulatory documentation to relevant authorities (e.g., FDA, EU MDR) for medical devices
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure products meet global regulatory requirements
Track and manage communication with all international Distributors, Authorized Representatives, and State License bodies
Monitor and interpret regulatory changes, providing guidance to internal teams
Submit change notifications to multiple Notified Bodies and EU Authorized Representatives
Maintain regulatory files and documentation in compliance with company policies and industry standards
Support post-market surveillance activities, including adverse event reporting and product labeling updates
Submit Label Checklists to the labeling team
Review and approve Change Orders related to manufacturing and address changes
Qualifications:
High school diploma or equivalent
Minimum of 1 year of experience in regulatory affairs within the medical device industry is required
Strong understanding of global regulatory requirements
Excellent communication and organizational skills
Comfortable using Microsoft Office Suite
Working Hours:
40 hours per week
Full-time
Remote
Monday- Friday
8:00 am - 4:30 pm
Details:
6-month contract role
Located in Carlsbad, San Diego, CA
Compensation: $20.00 - $22.00 per hour DOE
If you have the qualifications above and are interested in this opportunity, then please apply now. We are conducting interviews as soon as possible!
Pay Details:
$20.00 to $22.00 per hour
Search managed by:
Ciara NortonBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance
#J-18808-Ljbffr