Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.
Company: Disability Solutions
Location: Cincinnati
Posted on: May 6, 2024
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Job Description:
Robotics & Digital Solutions, part of the Johnson & Johnson
Medtech Surgery, is recruiting for a Senior Regulatory Affairs
Specialist . The preferred location for this role is within a
commutable distance of Cincinnati, OH however candidates within
commutable distance of Santa Clara, CA or Raritan, NJ will also be
considered . This role will work a Flex/Hybrid schedule with 3 days
per week on-site. About Johnson & Johnson At Johnson & Johnson, we
believe health is everything. Our strength in healthcare innovation
empowers us to build a world where complex diseases are prevented,
treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at In joining our growing regulatory team, the
Sr. Regulatory Affairs Specialist will help Robotics & Digital
Solutions reach US and international regulatory (NPD) approval
goals. Under minimal supervision, the selected candidate will be
working on the robotics, instruments and accessories portfolio RA
needs, working closely with exceptional engineering and clinical
teams, as well as supporting product development stages and
generating submission ready documentation and authoring regulatory
submissions. Additionally, this individual will support health
authority communications and participate in strategy development.
Key Responsibilities : --- Applies strategic regulatory thinking
along with technical expertise to implement regulatory strategies
for new product clearances and approvals. --- Prepares and submits
regulatory information required to obtain global market access
including preparation, writing and filing of FDA submissions
including 510(k)s and global health authorities' submissions
technical documents. --- Proactively identifies issues, effectively
communicates timelines for project completion, and addresses issues
that may impact registration status. --- Guides conformance with
applicable regulations and guidance documents in product
development, support of claims, content labeling, and promotional
materials. --- Assists in the development of Regulatory Affairs
processes. The base pay range for this position is $90,000 to
$130,000 ($105,000 to $150,000 for candidates in Santa Clara )
based on experience . The Company maintains highly competitive,
performance-based compensation programs. Under current guidelines,
this position is eligible for an annual performance bonus. The
annual performance bonus is a cash bonus intended to provide an
incentive to achieve annual targeted results by rewarding for
individual and the corporation's performance over a
calendar/performance year. Bonuses are awarded at the Company's
discretion on an individual basis. Employees may be eligible to
participate in Company employee benefit programs such as health
insurance, savings plan, pension plan, disability plan, vacation
pay, sick time, holiday pay, and work, personal and family time off
in accordance with the terms of the applicable plans. Additional
information can be found through the link below.
Keywords: Disability Solutions, Louisville , Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc., Other , Cincinnati, Kentucky
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