IntePros ยท 1 day ago
Sr Regulatory Affairs Specialists
United States
Part-time
Remote
Mid, Senior Level
$73/hr - $73/hr
4+ years expIntePros is seeking a Senior Regulatory Affairs Specialists to manage regulatory submissions and ensure compliance with various regulations. The role involves coordinating document packages, leading submissions, and recommending changes for compliance while mentoring lower-level specialists.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
May act as a mentor to colleagues or may direct the work of other lower level professionals
Delivering and overseeing the projects from design to implementation while and adhering to policies
Coaches and reviews the work of lower level specialists; may manage projects / processes
Works independently under limited supervision to determine and develop approach to solutions
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. (May be responsible for entire projects or processes within job area.)
Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements
Communicates with senior internal and external customers and vendors
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making
May provide guidance, coaching and training to other employees within job area
May manage projects, requiring delegation of work and review of others' work product
Qualification
Required
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Must have experience ISO 13485
Must have experience with 21 CFR part 820, 821, and EU 2017/745
Must have experience with 30 day, and 510k compiling
Must have experience with CAPA, PFMEA and FMEA
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
Company data provided by crunchbase