Senior Regulatory Affairs Program Lead – MedTech Surgery

Location

California

Posted

8 days ago

Salary

$125K - $201.3K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglishCyber Security

Job Description

Senior Regulatory Affairs Program Lead – MedTech Surgery

Johnson & Johnson

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator. • Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. • Prepares and submits regulatory information required to obtain global market access. • Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s). • Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. • Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status. • Guide conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. • Assists in the development and enhancement of Regulatory Affairs processes.

Job Requirements

  • Minimum of a Bachelor's Degree required
  • Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required
  • Experience with Class II medical device regulatory product submissions required
  • Previous experience with health authority meetings/interactions required
  • A demonstrated track record of developing and driving implementation of regulatory strategies.
  • Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML.
  • Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601).
  • Excellent communication skills for effective collaboration with cross-functional partners.
  • Strong attention to detail.
  • Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.

Benefits

  • Pension and savings plan (401(k))
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year

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