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Regulatory Affairs Specialist

Irvine, CA 92617

Posted: 09/08/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 585290 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
1. EU Labeling Requirements
2. EU MDR Regulation, ISO15223, ISO20417
3. Project Management and Change Management skills
  • 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 UDI and barcode grading processes and systems as related to product labeling
  • Other duties as assigned or required

 

Education Required: MS in Science, engineering or regulatory.

Years’ Experience Required: 3-4 years


 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 gain 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

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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