Manager, Regulatory Affairs

☞ Integra LifeSciences

View: 227

Update day: 24-04-2024

Location: Le Locle Neuchâtel NE

Category: Pharmaceutical / Chemical / Biotech

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Job content

Overview
Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.

At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.

Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.

Regardless of geographic location, our commitment is to offer the following, whenever possible:
  • Benefit plans that meet all local statutory requirements
  • A range of programs that reflect typical local market practices
  • An opportunity for employees to tailor benefits to their specific needs
  • Benefits that balance employee’s short-term and long-term needs
Click HERE for more information regarding our benefits and total rewards program
Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight.

  • Manages timely regulatory submission and approvals for the US (FDA) and EU (CE marking)
  • Coordinates/prepares/approves/maintains FDA 510(k) Premarket Notifications in accordance with US FDA requirements
  • Coordinates/prepares/approves/maintains CE files in accordance with current Medical Device Regulations (MDR) requirements
  • Provides regulatory guidance to cross-functional groups
  • Represent regulatory on project planning, project teams, risk management, and review meetings.
  • Participates in health hazard assessments and regulatory field actions
  • Develops/approves US and EU regulatory strategies and regulatory plans
  • Communicates with US FDA, EU Notified Bodies, EU Competent Authorities
  • Coordinates/prepares/approves responses to FDA/NB or other such regulatory agency letters.
  • Prepares/approves 510(k) Decision Trees as required to support changes
  • Reviews and approves product labeling
  • Reviews and approves promotional literature and marketing materials
  • Keeps apprised of new US/EU regulations, policies, and guidance issued by relevant regulatory authorities that may impact the company
  • Participates in regulatory audits/inspections as required
  • Ensures the company meets its goals while maintaining regulatory compliance
  • Writes SOPs and train key personnel as needed
  • Provides input for the preparation of departmental budget and participates in the department operating within operating budget
  • Perform other duties as assigned
Qualifications
Education:
A Bachelor’s degree (or international equivalent degree) in biology, chemistry, engineering or related technical field is desired.

Experience:
  • 5-7 years of experience preparing US/EU regulatory strategies/submissions for medical devices.
  • This individual must have proven skills in the planning, coordination and approval of CE registrations and US 510(k) Premarket Notifications.
  • This individual must possess and demonstrate an excellent understanding of US FDA regulations and European Medical Device Directive (MDD) and be familiar with the new EU requirements under MDR
  • This individual must have experience working with US FDA, European Notified Bodies and Competent Authorities
  • The individual must have strong writing, project management, data analysis, and communication skills. The individual must have the ability to handle multiple demanding projects.
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Deadline: 08-06-2024

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