Be an early applicantLess than 25 applicantsPosted by Agency

Company

IntePros · 2 days ago

Sr Regulatory Affairs Specialists

United States

Part-time

Remote

Mid, Senior Level

$73/hr - $73/hr

4+ years exp

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ConsultingInformation Technology

Senior Management

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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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ISO 1348521 CFR part 82021 CFR part 821EU 2017/74530 day compiling510k compilingCAPAPFMEAFMEAUniversity DegreeAdvanced Degree

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 a results-oriented recruiting solutions and staffing company that uses our Top Gun Recruiting Engine to attract, recruit, and retain elite IT consultants on behalf of our roster of market-leading clients.

Founded in 1996

Lexington, Massachusetts, USA

201-500 employees