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Sr Spec, Regulatory Affairs

Irvine, CA 92606

Posted: 07/25/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 607779 Is job remote?: No Country: United States

Job Description


Target PR Range: 38-48/hr
*Depending on experience

Summary:

The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.

Key Responsibilities:
  • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
  • Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
  • Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
  • Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.
  • Other incidental duties assigned by Leadership.

Additional Skills:
  • Coursework, seminars, and/or other formal government and/or trade association training required
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Good written and verbal communication skills and interpersonal relationship skills
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
  • Solid knowledge and understanding of global regulatory requirements for new products or product changes.
  • Solid knowledge of new product development systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
  • Ability to build productive internal/external working relationships
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:
  • Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
  • 5-7 years of experience required

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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About Irvine, CA

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, 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.