Regulatory Affairs Specialist (Remote) - Remote
San Diego, California
Contract/Temporary
$21.00 - $23.00 per Hour
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.
Review and approve change orders related to manufacturing and address updates.
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 Remote Duration: 6+ months Hours: 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!
Pay Details: $21.00 to $23.00 per hour Search managed by: Alicia FritzalBenefit 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 subject to federal contractor requirements and/or security clearance requirements.
Regulatory Affairs Specialist (Remote) - Remote
LHH
14 days ago
$21.00 - $23.00 per Hour
Contract/Temporary
San Diego, California
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.
Review and approve change orders related to manufacturing and address updates.
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 Remote Duration: 6+ months Hours: 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!
Pay Details: $21.00 to $23.00 per hour Search managed by: Alicia FritzalBenefit 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 subject to federal contractor requirements and/or security clearance requirements.