Sr. Regulatory Specialist

Sr. Regulatory Specialist

The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals/clearances and maintain overall regulatory compliance for the company.

Key Responsibilities

• With minimal oversight, preparing and maintaining pre-market submissions or post-market change submissions for a variety of markets.
• With minimal oversight, provide project-level regulatory strategy and support for new product development projects, postmarket lifecycle projects, Quality System updates, business development projects:
  • Project team RA lead member
  • Assess and approve post-market changes
  • Assess and approve product and process Nonconformances and deviations
  • Own and execute CAPA for Regulatory processes

Skills Knowledge and Expertise

• Bachelor's Degree from an accredited institution required

• Minimum 5 years experience in FDA/ISO medical devices quality management system standards required
• 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required

• Technical writing skills required

About Advita Ortho

At Advita Ortho, everything we do is focused on innovation. Whether creating revolutionary ways to optimize the surgical experience, developing the latest in orthopedic implants and instruments, or using cutting-edge technology to improve efficacy and outcomes. These advancements transform the very experience of mobility and allow you to lead your patients to greater freedom. It's innovation in every step, every moment, every move. Apply Now

Our Hiring Process

Stage 2: Hiring Manager and Team Interview(s)

Stage 3: Final Selection

Stage 4: Offer

Stage 1: Initial Interview