Regulatory Affairs Specialist
Posted on: November 18, 2021
A bit about us:
New up an coming company making major moves in the medical device
Why join us?
Great pay, benefits and work life balance
Is your background a fit? Apply if you meet this criteria:
- Provides guidance on regulatory requirements necessary for
strategic and contingency planning, including developing regulatory
strategic plans to teams for solutions.
- Represents regulatory affairs on product development and
- Ensures compliance with standards and execution of corrective
actions and is the liaison with domestic and international
customers and vendors.
- Prepares and oversees documentation packages for submission to
global regulatory agencies. Tracks timelines and documents
milestone achievements for inclusion in regulatory submissions.
Interacts with regulatory agencies as part of submission review and
on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s,
STEDs, and CE marking design dossiers and technical files).
- Assists with customer complaints/CAPA system.
- Develops risk assessment review process for all marketed
devices and implementation of changes to risk management process as
- Monitors proposed and current US and EU regulations and
guidance and advises on the impact of such regulations.
- Reviews documents for regulatory claims, promotional material,
labeling content, product and process changes, and product
- Collaborates and takes direction from RA management.
- Strong working knowledge of US and EU regulations that affect
Class III medical devices.
- Experience working on cross functional projects.
- Fluent English with strong written and verbal communication
- Excellent analytical thinking and problem-solving skills.
- 3 years of experience in a regulatory role or related area.
- Interpersonal Effectiveness: Actively seeks to understand
perspectives and interpersonal needs and expectations of others at
all levels, builds self-awareness, flexes personal style
appropriately, and works through conflicts constructively and
- Communication: Effectively uses all mediums of communication as
appropriate, presents well to groups, actively listens, and
continuously identifies opportunities to build communication
- Collaboration & Teamwork: Actively works together with formal
and informal team members to build relationships and achieve team
- Prioritization: Effectively prioritizes work to ensure timely
completion of work within scope
- Technical Expertise: Continuously builds functional and
technical expertise, and pro-actively applies that technical
expertise in progressively broader scope
- Continuous Improvement: Learns and uses best practices tools
and methodologies to assess, identify, and executes on
opportunities to improve; Focus on learning and building new
capabilities into self
- Problem Solving & Problem Prevention: Learns and uses strong
problem solving methodologies and tools, focuses on root cause
analysis, and shows orientation towards problem prevention
- Accountability: Focuses on results, takes initiative without
direction, takes ownership for all work within scope, builds
relationships and works across departments, functions, or areas of
Keywords: Jobot, Irvine , Regulatory Affairs Specialist, Other , Irvine, California
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