Senior Regulatory Affairs Program Lead (Biosurgery) - Ethicon, Inc. - Johnson and Johnson
San Lorenzo, PR 00754
About the Job
About Johnson & Johnson
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.
Are you an experienced individual contributor looking for a new opportunity with end-to-end responsibility for the life cycle maintenance and new product development launches within the Biosurgery portfolio? As the Senior Regulatory Affairs Program Lead, you will provide independent regulatory guidance to product development teams, ensuring optimal timelines for new/modified product launches. This is your chance to make an impact and be part of a world-class team at Johnson & Johnson.
Key Responsibilities :
• Lead the overall strategy development, implementation, and coordination of regulatory affairs activities for Class II, Class III medical devices, combination products, and biologics, with minimal guidance.
• Evaluate regulatory pathways, formulate a comprehensive global strategy, and complete regulatory submissions for the purpose of obtaining registration for upcoming products.
• Apply strategic regulatory thinking and technical expertise to implement regulatory strategies for product clearances and approvals.
• Manage MDR updates and coordinate with the MDR execution team.
• Review changes made to existing products to assess the impact on safety and effectiveness and determine the appropriate regulatory pathway for implementation.
• Review advertisement and promotional product material to ensure compliance with regulations.
• Monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's portfolio of products.
• Oversee the regulatory aspects of new product launches.
• Make independent decisions regarding work processes or operational plans and schedules.
• Provide Regulatory Affairs support during internal and external audits.
• Contribute to the enhancement of Regulatory Affairs processes and systems by assisting in the development of effective practices. Minimum Qualifications :
• Minimum of a Bachelor's degree required; Advanced Degree strongly preferred .
• At least 5 years of regulatory affairs or related experience required.
• Experience with authoring and managing Class III (US and EU) medical device submissions required.
• Previous experience working with cross-functional product development teams.
• Ability to work independently and collaborate with a large team to achieve project success.
• Excellent written and verbal communication skills.
• Previous experience reviewing various changes made to existing products to assess the impact on safety and effectiveness.
• Previous experience within product development, support of claims, content labeling, and promotional materials strongly preferred .
• Previous experience with medical device product launches highly desired .
• Fluency in English is required.
• Limited national and international travel may be required.
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is desirable .
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 .