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Meet
, CA, United States
Meets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's r
Job Source: MeetConfidential
Los Angeles, CA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA interact
Job Source: ConfidentialAbbott Laboratories company
Los Angeles, CA, United States
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Source: Abbott Laboratories companyAmgen Inc. (IR)
Los Angeles, CA, United States
Executive Director, Regulatory Affairs page is loaded Executive Director, Regulatory Affairs Apply remote type Remote locations US - California - Los Angeles time type Full time posted on Posted 2 Days Ago job requisition id R-190059 Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMA
Job Source: Amgen Inc. (IR)BioSpace, Inc.
Los Angeles, CA, United States
Job Details HOW MIGHT YOU DEFY IMAGINATION? At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to le
Job Source: BioSpace, Inc.Amgen
Los Angeles, CA, United States
HOW MIGHT YOU DEFY IMAGINATION? At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge p
Job Source: AmgenMeet
, CA, United States
Senior Director, Regulatory Affairs (Generalist) Remote Position for West Coast-based candidates, frequent travel to Bay Area required Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs an
Job Source: MeetBayside Solutions
, CA, United States
Director, CMC Regulatory Affairs Direct Hire Full-Time Role Salary Range: $208,000 - $235,000 per year Location: Redwood City, CA - Hybrid Role Job Summary: The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual mark
Job Source: Bayside Solutions, CA, United States
This individual will join our client's regulatory team and collaborate with other departments like R&D, Manufacturing, Quality Assurance, and Commercial. Here's what you'll be responsible for:
Preparing Regulatory Submissions: You'll draft submissions for international markets and the FDA, including Technical Documents, Files, Device Applications/Amendments, and PMAs.
Data Gathering and Support: Identify and collect data needed for filings, responses to inquiries, and registration maintenance. This ensures products meet global regulatory requirements for commercialization.
Clinical Evaluation Reports: You'll be responsible for creating and updating annual Clinical Evaluation Reports, including State of the Art and Subject Literature Reviews.
Regulatory Submissions Expertise: As a key contributor, you'll prepare and review submissions following US and international regulatory requirements. You'll also ensure complete and timely responses to Health Authorities during application review.
Subject Matter Expert: Serve as a resource on regulatory affairs, providing training and guidance to team members as needed.
Regulatory Procedures: Author and/or review regulatory procedures and update them when necessary.
Regulatory Knowledge: Possess a strong understanding of medical device regulations, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks.
Communication and Collaboration: Demonstrate excellent communication skills and collaborate effectively with cross-functional teams.
Project Team Participation: Actively participate in cross-functional project teams as a global regulatory advisor.
Technical Documentation Review: Review technical documentation to ensure it supports regulatory applications.
Competitive and Technical Awareness: Maintain a strong understanding of competitive technologies and medical/technical developments relevant to our client's products.
What You Bring to the Table:
Proven Regulatory Experience: This role requires strong experience with pre-market regulatory activities in the US, EU, and other global markets.
Success with Regulatory Agencies: You have a proven track record of successful regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
Fast-Paced Environment: You thrive in a dynamic and fast-paced work environment.
Integrity and Character: You possess high integrity, character, and are a person who is tough-minded, fair, and principled.
Creative Problem-Solving: You have strong analytical and problem-solving skills with the ability to develop innovative solutions.
Project Management Skills: You can prioritize tasks, manage multiple projects, and set/manage timelines with urgency.
Communication and Interpersonal Skills: You are self-confident, decisive, and possess excellent communication skills in both written and oral formats. Additionally, you are a great listener, presenter, and problem solver.
Teamwork and Collaboration: You can interface effectively at all levels and functions within the organization.
Supervisory Responsibilities:
Manage internal and external resources.
Education and Experience:
7-10 years of experience in regulatory affairs within the medical device industry, with a preference for implantable devices.
Bachelor's or master's degree.
A "hands-on" style that fosters a strong, cohesive, team-focused work environment.
Technical and continuous improvement experience with emphasis on managing and deploying continuous product development for medical devices.
A proven track record in therapy innovation, technology implementation, and commercialization.
A demonstrable track record of achieving and maintaining high-quality standards.
Complete training as outlined in the company's training plan, including mandatory training on Insider Trading, Anti-Bribery/Corruption Policies, and Code of Business Conduct and Ethics.
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Email Alert for Director of Regulatory Affairs jobs in , CA, United States
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