MDR - Regulatory Affairs Specialist
Company: Integrated Resources, Inc
Posted on: November 22, 2021
Top 3 skills required:
1. EU MDR support
2. Medical device experience
3. Good communication skills.
Manager will consider remote candidates anywhere in the US.
Responsibilities may include the following and other duties may be
assigned. Directs or performs coordination and preparation of
document packages for regulatory submissions from all areas of
company, internal audits and inspections. Leads or compiles all
materials required in submissions, license renewal and annual
registrations. Recommends changes for labeling, manufacturing,
marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems. Keeps abreast of
regulatory procedures and changes. May direct interaction with
regulatory agencies on defined matters. Recommends strategies for
earliest possible approvals of clinical trials applications.
SPECIALIST CAREER STREAM: Typically an individual contributor with
responsibility in a professional discipline or specialty. 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. The
majority of time is spent delivering and overseeing the projects
from design to implementation while and adhering to policies, using
specialized knowledge and skills normally acquired through advanced
education (typically University).
DIFFERENTIATING FACTORS Autonomy: Established and productive
individual contributor. Works independently with general
supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the
objectives of projects and assignments. Contributes to the
completion of project milestones . May have some involvement in
cross functional assignments. Innovation and Complexity: Problems
and issues faced are general, and may require understanding of
broader set of issues or other job areas but typically are not
complex . Makes adjustments or recommends enhancements in systems
and processes to solve problems or improve effectiveness of job
area. Communication and Influence: Communicates primarily and
frequently with internal contacts . External interactions are less
complex or problem solving in nature. Contacts others to share
information, status, needs and issues in order to inform, Product
input, and support decisionmaking. Leadership and Talent
Management: May provide guidance and assistance to entry level
professionals and / or employee in Support Career Stream. Required
Knowledge and Experience: Requires practical knowledge and
demonstrated competence within job area typically obtained through
advanced education combined with experience.
Requires a University Degree and minimum of 2 years of relevant
experience, or advanced degree with 0 years of experience.
Keywords: Integrated Resources, Inc, Irvine , MDR - Regulatory Affairs Specialist, Other , Irvine, California
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