Regulatory Compliance Specialist

Company: Endologix
Location: Irvine
Posted on: May 16, 2022

Job Description:

This role will serve the Regulatory Affairs department in compliance activities. Specifically, the specialist will provide regulatory compliance support for assigned project teams and will complete projects and tasks to established timelines to meet corporate objectives. This includes supporting internal/external audits and recall activities. Ensures compliance with state, federal, and International medical device regulations and overall regulatory department objectives. Negotiates the content and structure of regulatory compliance filings with international partners, agents, and distributors. Responsibilities

• Supports RA Compliance department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
• Under the direction of Regulatory Affairs Management, executes regulatory and compliance aspects for any field corrective actions in a timely, thorough, and transparent manner. Collaborates with cross-functional personnel to complete Health Hazard Evaluations, develops reports for submission to global regulatory authorities, responds to requests for information, and maintains recall records.
• In collaboration with Regulatory Management, assists in the preparation and management of internal audits as well as external audits with global regulatory agencies. Collaborates with cross-functional personnel to complete and submit high quality responses to identified audit non-conformances and observations.
• Reviews, completes, and/or approves document change orders (DCOs), Notice of Regulatory Approvals (NORAs), CAPA plans and reports, action items, and other documents as a member of assigned project teams.
• Develops, prepares, and submits high quality technical information for submission in geographies. Establishes timelines, manages sub-team meetings relevant to the regulatory compliance processes, and ensures timely execution.
• Negotiates with international staff, agents, and distributors on technical data and submission filing contents. Interacts with international representatives in a respectful, professional manner to ensure regulatory submission projects remain on track and issues or queries are identified and resolved in conjunction with project teams as expediently as possible.
• Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
• Up to 30% travel anticipated Qualifications
  • Good interpersonal skills including ability to interact with high degree of diplomacy.
  • Extensive knowledge of medical device regulations.
  • Comprehensive knowledge of quality systems and relationship to business.
  • Complete understanding and wide application of technical or regulatory principles, theories, and concepts. General knowledge of other related disciplines.
  • Ability to facilitate and provide input when interpreting regulatory standards and guidance documents.
  • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
  • Must be self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities within internal and external commitment dates.
  • Effective problem-solving skills.
  • Excellent applied thinking skills and technical writing skills.
  • Strong communication, and organization skills required.
  • Expertise in Microsoft Office applications and charting programs. Education: Minimum bachelor's degree in a scientific discipline or equivalent. Experience: 3+ years of experience with a Bachelor's degree, 1 year of experience with a Master's degree.

Keywords: Endologix, Irvine , Regulatory Compliance Specialist, Other , Irvine, California