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Regulatory Affairs Specialist

2 months ago

Thousand Oaks, California, United States Accordance Search Group Full time
Regulatory Specialist Job Description

Job Summary: We are seeking a highly skilled Regulatory Specialist to join our team at Accordance Search Group. As a key member of our regulatory affairs team, you will be responsible for providing comprehensive regulatory support for new product launches and existing product lines.

Key Responsibilities:

  • Offer regulatory guidance and input to cross-functional teams, developing and implementing global regulatory strategies for various devices.
  • Prepare and submit regulatory submissions for both U.S. and international markets.
  • Prepare and manage Technical Files, Design Dossiers, Change Notifications, and Submissions for regulatory agencies and distributors.
  • Create, review, and approve change requests to ensure compliance with regulatory requirements.
  • Assist in defining regulatory strategies and manage submission activities for complex product development projects and the maintenance of approved products.
  • Interpret and apply new or existing regulatory requirements to the product portfolio and regulatory and quality system procedures.
  • Support or prepare regulatory submissions for new products and product changes, ensuring timely market release approvals.
  • Review protocols and reports to support regulatory submissions.
  • Maintain up-to-date knowledge of global quality and regulatory requirements.
  • Demonstrate strong project management skills, particularly in the writing, coordination, and execution of regulatory tasks, with an emphasis on technical and scientific activities.
  • Provide regulatory input for product lifecycle planning and ongoing support to product development teams.
  • Support clinical studies by preparing and submitting regulatory documents, facilitating site interactions, addressing site requests, and maintaining study documentation.

Requirements:

  • B.S. degree in Biomedical Engineering, Biotechnology, Regulatory Sciences, or a related field.
  • Certifications with RAPS, ASQ, or CQE are preferred.
  • 3-5 years of experience in International Regulatory Affairs, preferably within the Medical Device industry.
  • Experience with Class II medical devices, including implants.
  • Familiarity with 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and European Medical Device Regulation 2017/745.
  • Working knowledge of ISO 13485 and ISO 14971 standards.

Desired Qualifications:

  • Experience with clinical studies and medical device software requirements and regulations.
  • Ability to work effectively within project teams and manage multiple priorities with minimal oversight.
  • Strong analytical and problem-solving skills, with the ability to identify risks and escalate issues as needed.
  • Prior involvement with product development teams and a solid understanding of the product development process and design control.
  • Proficiency in writing clear, understandable technical documents, including regulatory documentation and scientific presentations.
  • Experience in data analysis and providing informed recommendations based on assembled facts.
  • Strong organizational skills, attention to detail, and a process-oriented approach.
  • Effective interpersonal and communication skills.
  • Experience supporting products from concept through end-of-life phases.
  • Proficiency in MS Office Suite (Word, Excel, PowerPoint, and Adobe).
  • Regulatory Affairs Certification (RAC) is a plus.

Accordance Search Group is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.