Job type: Full-time

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DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Manager - Digital, located in West Chester, PA; Warsaw, Indiana; Zuchwil or Oberdorf Switzerland; or any location in US / EU for the right candidate. Remote work options may be considered, on a case-by-case basis and if approved by the Company.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Key Responsibilities
  • Lead, Direct, and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
  • Provide mentorship to project team members regarding regulatory compliance issues.
  • Lead all aspects of the preparation and maintenance of regulatory submissions and files.
  • Establish accountability for the preparation of vital outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
  • Interact with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
  • Collaborate with management personnel to establish and prepare appropriate regulatory filings for product approvals.
  • Work with team members and commercial partners to be responsible for the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses.
  • Ensure organizational compliance with all applicable regulations and J&J policies.
  • Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).

Qualifications

Education:
  • A minimum of Bachelor’s Degree in a scientific, engineering, business, or legal disciple is required (Master’s and/or PhD desired)
  • At least 6 years of regulatory experience (4 years with Master’s and 3 years with PhD)
  • Experience with US and European medical device regulatory processes required
  • Proven track record of developing and implementing global regulatory strategies that align with business results
  • Leadership experience
Preferred Skills & Experience:
  • Knowledge of Digital technologies including SaMD, SiMD, Robotics, etc., desired
  • Experience working with professional and trade associations
  • Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as European Technical Files and Design Dossiers
  • Must have excellent written, verbal communication and presentation skill required. People management experience preferred.
Other:

This position can be located in USA or EU for the right candidate and may require up to 10% domestic/international travel.

Remote work options may be considered on a case-by-case basis and if approved by the company.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

The base pay range for this position is $106k to midpoint $160K.

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.

Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States---

Other Locations

Europe/Middle East/Africa, North America-United States-Pennsylvania-West Chester, Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil, United States-Indiana-Warsaw

Organization

Medical Device Business Services, Inc (6029)

Job Function

Regulatory Affairs

Requisition ID

2206003432W

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Deadline: 05-05-2024

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