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Regulatory Affairs Specialist
5290 California Avenue Irvine, CA 92617 US
Job Description
HM's Top Needs:
1. EU Labeling Requirements
2. Global labeling requirements, 21 CFR 801, EU MDR Regulation, ISO15223, ISO20417
3. Project Management and Change Management skills
Education Required: MS in Science, engineering or regulatory.
Years’ Experience Required: 5-9 years
Will the contractor be working 40 hours a week? If not, weekly estimate? 40
Work Location: Irvine
Do they need to be local to any MDT office and if so where? Irvine or near by
Does this person need to be on site? If so, full time or part time? Onsite - minimum 4 days
- Accountable for the regulatory labeling deliverables for various project types (i.e. submission, new product development, sustaining, launches, manufacturing transfer, etc.)
- Manage and support assessment and template creation for new and changing requirements.
- Prepare technical product documentation including plans, reports, and engineering change orders, etc.
- Maintain artwork content for all labeling types including Instructions for Use documents, product labels, Patient labeling, electronic labeling, label stocks, and carton in compliance with applicable regulations, standards, company policies, processes as well as internal labeling requirements.
- Estimates labeling projects level of effort, resource requirements and works with stakeholders to understand the scope of effort and tasks necessary to complete the project.
- Collaborate with multi-functional team (R&D engineering, marketing, manufacturing, operations, regulatory, legal, quality, clinical, medical safety) to facilitate completion of labeling artwork projects
- Tracks labeling project schedules, identify risks/issues, determine resolution and communicates project status or escalations by participating in departmental and project team meetings.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Manage labeling, UDI and barcode grading processes and systems as related to product labeling
- Other duties as assigned or required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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