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Form of workDePuy Synthes is currently recruiting for a Project Manager, Regulatory Affairs to support New Product Development and Life Cycle Management. This role will work a Hybrid/Flex schedule with 3 days in office each week, located in Raynham, MA.
DePuy Synthes, the Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.
Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow.
The Project Manager, Regulatory Affairs will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Sports Medicine line of products. This role involves a dynamic set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.
Key Responsibilities :
• Represent Regulatory Affairs on development core teams, providing regulatory feedback and guidance throughout the product development cycle.
• Research, develop, and implement regulatory strategies for new and modified Medical Devices.
• Compiles regulatory submissions, filing amendments and correspondence with U.S. and EU regulatory authorities.
• Act as company representative under minimal direction, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, and submission reviews.
• Collaborates closely with international regulatory associates to develop international regulatory strategies to ensure the successful registration of devices worldwide. Address and resolve requests for additional information.
• Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.
• Participates in process improvement and corporate initiatives, as appropriate.
• Prepares for and assists with external audits such as MDSAP or Notified Body audits.
• Maintain knowledge of current applicable regulations and guidance documents.
• Maintains the highest levels of professionalism, ethics and compliance at all times. Required Qualifications :
• Minimum of a Bachelor's Degree required; Advanced Degree preferred.
• Minimum 6 years of regulatory experience in the Medical Device or related (IVD) field.
• Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives).
• Proven success in the preparation and completion of US, EU, or international regulatory submissions.
• Experience and understanding of product development process and design controls.
Preferred:
• Experience in orthopaedics and orthopaedic device regulatory requirements strongly preferred .
• Strong Project Management skills highly desired .
• Demonstrated global perspective, cross-functional collaboration and partnership skills.
• Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.).
• Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part.
• Excellent written and oral communication skills.
• Ability to balance multiple tasks with attention to detail with limited supervision.
Other:
• This position is located in Raynham, MA and may require up to 10% travel, domestic and/or international.
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.
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.
This job posting is anticipated to close on 2/14/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
