elemed · 10 hours ago
Regulatory Affairs Manager
Houston, TX
Full-time
Onsite
Senior Level
5+ years expElemed is a leading MedTech staffing agency that specializes in the medical device, diagnostic, and biotech sectors. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory strategies and requirements for the Neuromodulation product, managing premarketing and regulatory activities, and maintaining relationships with regulatory authorities.
Medical Device
Hiring Manager
Samuel Crossman
Responsibilities
Participate on project development teams to ensure that appropriate regulatory strategies are communicated, and regulatory requirements are met
Take care of the preparation and editing of the technical and formal documentation necessary to get registrations and keep them in compliance with product changes with a particular focus on the international Area
Manage premarketing, maintenance and renewal regulatory activities for the manufacturing site in the international Region, in collaboration with the regional regulatory team
Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies in Europe and in the International Area
Distribute appropriate notifications for product approvals and report on the status of approvals to appropriate company functions
Monitor, verify and review product documentation (Instructions for use, brochures, Company website, etc.) to ensure compliance with relevant law requirements
Interface/correspond with government agencies, industry organizations, distributors, and international personnel to keep abreast of regulatory requirements
Provide necessary/requested information and materials to government agencies, distributors, and international personnel to meet regulatory requirements
Assist if required during facility audits/assessments by government agencies
Keep up to a high level of knowledge and comprehension of laws and regulations impacting on Company products
Qualification
Required
Technical Scientific University degree
5+ years' experience in the field of regulatory affairs; product conformity obtained, at least in part, in Companies in the Medical Device sector
Knowledge of standards and regulations related to medical devices in EU and US (EUMDR, ISO 13485, 21CFR820) as well as in the international area
Knowledge of the fundamentals of SAMD, digital health or AI regulations
Ability and experience in preparation of technical and formal documentation necessary for submission and assessment at Notified Bodies and/or Competent Authorities
Preparation of organizational procedures
Preferred
RAPS Society RAC designation is a plus
Benefits
1:1 mentorship from a highly experienced mentor
Join hundreds of fellow regulatory, quality and clinical professionals in Elemed’s RQC Network
Attend expert-led masterclasses
Company
elemed
We're on a mission to accelerate the availability of healthcare products through the power of people. Because healthcare touches us all.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase