| Location | San Diego, CA (Remote) |
| Salary | $40–$57 Per Hour |
Regulatory Affairs Specialist (Remote)
LHH has partnered with an established medical device company that is searching for a Regulatory Affairs Specialist to assist their team on a contract basis. They are seeking a highly skilled Regulatory Affairs Specialist with a strong background in the medical device industry. The ideal candidate will have a minimum of 2 years of regulatory experience and possess exceptional technical writing skills, particularly in relation to EU regulations. This is a fully remote position.
Key Responsibilities:
Develop and execute regulatory strategies to ensure compliance with EU regulations and industry standards.
Prepare, review, and submit regulatory documentation, including technical files, dossiers, device-change documentation, and letters to file.
Interface with regulatory authorities and notified bodies to support product approvals, certifications, and compliance activities.
Conduct regulatory gap assessments, change assessments, and document reviews to maintain regulatory readiness.
Monitor regulatory requirements and communicate changes to cross-functional teams.
Provide regulatory support to Quality, R&D, Engineering, Manufacturing, and other stakeholders.
Support regulatory quality plans, remediation efforts, and EU-focused initiatives.
Track deliverables, deadlines, and action items while escalating risks and providing status updates.
Maintain regulatory operations during team absences and support post-market surveillance and other special projects as needed.
Qualifications:
2+ years of regulatory affairs experience in the medical devices industry
U.S. FDA and international industry experience
Experience with gap assessments and change assessments
Experience drafting or supporting letters to file
Regulatory documentation and documentation pre-review experience
Strong technical writing skills with experience in preparing regulatory submissions for EU regulations
Excellent communication and interpersonal skills
Ability to work independently and as part of a team in a remote work environment
Additional Details:
Location: FULLY REMOTE
Pay: $40.00-$57.00/ hour based on experience
Schedule: Monday-Friday, standard business hours
Duration: Contract for approx. 6 months
If you are a motivated and experienced Regulatory Affairs Specialist looking to make a significant impact in a cutting-edge industry, please apply today!
Pay Details: $40.00 to $57.00 per hour
Search managed by: Alicia Fritzal
Benefit 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
Military connected talent encouraged to apply
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:
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.