Senior Specialist in Regulatory Compliance

2 weeks ago

Carlsbad, United States Alphatec Spine Full time

Position Overview
As a Senior Regulatory Affairs Specialist, you will play a crucial role in the development and submission of regulatory documents for both domestic and international spinal products. Your expertise will support our spinal product design teams in navigating change control processes and regulatory submissions.

Key Responsibilities
Your responsibilities will include:

  1. Providing strategic guidance on domestic and international regulatory pathways for products, including spinal devices, software as a medical device (SaMD), and radiation-emitting devices;
  2. Supporting design control processes for spinal devices and associated medical software;
  3. Implementing IEC 62304 standards throughout the software development lifecycle for regulatory submissions;
  4. Preparing and submitting regulatory documents, including 510(k) premarket notifications to the FDA;
  5. Maintaining FDA establishment listings and registrations;
  6. Drafting technical files and design dossiers for spinal product registrations in regions such as the European Union, Australia, and New Zealand, while collaborating with Notified Bodies on significant product changes;
  7. Enhancing internal processes, evaluating data metrics, and managing databases related to regulatory submissions for spinal products;
  8. Assisting in post-market surveillance activities, including evaluation, trending, and reporting for spinal products, and updating risk management processes;
  9. Reviewing labeling and promotional materials for compliance with regulatory approvals;
  10. Conducting research on regulatory information sources, including agency websites and standards organizations;
  11. Providing support during internal and external regulatory audits;
  12. Developing, maintaining, and tracking company Standard Operating Procedures (SOPs) to ensure adherence to global regulatory standards.

Qualifications
To be considered for this role, candidates should possess:

  • A Master's degree or foreign equivalent in Regulatory Affairs, Biomedical Engineering, Biology, or a closely related field, along with 2 years of relevant post-baccalaureate experience; or
  • A Bachelor's degree or foreign equivalent in the same fields, accompanied by 5 years of relevant post-baccalaureate experience.

Experience Requirements
Candidates must have the following experience:

  1. At least 2 years of experience with 510(k) submissions;
  2. 2 years of familiarity with FDA Quality System Requirements (QSR) and ISO 13485;
  3. 2 years of experience with MDD 93/42/EEC, MDR 2017/745, and New Zealand quality system standards;
  4. 2 years of knowledge regarding orthopedic or spinal devices and their clinical applications;
  5. 2 years of experience with medical devices that include software and SaMD;
  6. 2 years of experience in determining regulatory strategies for spinal or software-based medical devices;
  7. 2 years of experience liaising with regulatory agencies and supporting audits for medical device products;
  8. 1 year of experience reviewing labeling and promotional materials;
  9. 1 year of experience in process improvement activities within a Quality Management System (QMS);
  10. 1 year of experience in maintaining FDA establishment registration and device listings.

This position offers the flexibility of telecommuting part of the week, in accordance with the company's flexible working policy.

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