Senior Regulatory Affairs Specialist

3 weeks ago

Irvine, United States Infosoft, Inc. Full time

Job Title: Senior Regulatory Affairs Specialist

Duration: 9 months

Location: Irvine, CA (Onsite)

Shift: 8 am to 5 pm.

Our Client is a Global medical device Manufacturer.

We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.

  • Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS 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 the 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 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.

Requirements:

  • Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
  • 3-5 years of regulatory affairs or related experience in a medical device, pharma, or a related industry. International regulatory affairs experience is desired
  • Excel spreadsheet
  • Design history files experience is desired.
  • Team player, strong communicator, and problem solver.
  • Experience with Ignite, LMS
  • 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 the environment and prevention of pollution under their span of influence/control

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