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Regulatory Affairs Advisor

3 weeks ago
United States
Full-time
Lead
Compliance Manager
Legal
HIPAA
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 110

Description

  • Develop and execute regulatory strategies for complex regulatory affairs programs, with emphasis on IVD systems such as hardware, software, and reagents.
  • Prepare and coordinate regulatory submissions with minimal supervision, including EU/IVD Technical Documentation, 510(k) premarket notifications, pre-submissions, investigational device exemptions, NYS DoH submissions, and global registrations.
  • Advocate for least burdensome regulatory approaches to product clearance and approval while interpreting regulatory requirements.
  • Communicate with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, labeling, and related submissions or registrations.
  • Evaluate product changes for global regulatory impact and determine submission implications.
  • Review and ensure compliance of advertising, promotion, and labeling for a common product line.
  • Represent Regulatory Affairs on core teams and change control initiatives, including cross-functional and cross-business efforts.
  • Mentor regulatory associates, support staff development, and deliver regulatory training.
  • Maintain product registrations, change assessments, post-market surveillance reports, and records of communication with regulatory authorities.
  • Support process improvements, regulatory initiatives, and occasional special projects to advance department goals.

Requirements

  • Bachelor’s degree in a life science field such as biology, microbiology, chemistry, engineering, medical technology, or regulatory science, or equivalent experience.
  • Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.
  • RAC certification preferred.
  • Minimum of 12 years of direct applicable regulatory experience in medical devices.
  • IVD experience and companion diagnostics experience are a plus.
  • PMA experience preferred.
  • Minimum of 5 years of managerial experience preferred.
  • Working knowledge of U.S. and EU medical device/IVD regulatory requirements.
  • Strong written and verbal communication skills, including the ability to negotiate with regulators and communicate across cultures.
  • Computer literacy with PC and Microsoft Word, Excel, and PowerPoint.

Benefits

  • Remote USA role with a salary range of $146,100 to $182,600 USD.
  • Comprehensive medical, dental, vision, life, and disability insurance for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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