Senior Regulatory Affairs Specialist (EES) - MedTech Surgery, Inc.

DescriptionMedTech Surgery, part of Johnson & Johnson MedTech, is currently recruiting for a Senior Regulatory Affairs Specialist. This role will work a Flex/Hybrid schedule and must be based within a commutable distance of Cincinnati, OH. There is NO remote option.About Johnson & JohnsonAt 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 https://www.jnj.com/.The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Senior Regulatory Affairs Specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of Ethicon products for compliance to global regulations and company policies and procedures. In conjunction with other functions they support post market and provide lead external and Internal audits.Primary Responsibilities:

• Prepares regulatory documentation for Ethicon devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
• Provides support in preparation, writing and submission of global registration activities requirements for New Product Development projects.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact
• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, etc.).
• Perform other duties as assigned.
  
  

QualificationsMinimum Requirements:

• Minimum of a Bachelor’s degree required, Advanced Degree strongly preferred; desired fields of study include science, biomedical engineering, medical / scientific writing, public health administration.
• Minimum of 5 years of Regulatory Affairs or related/equivalent experience required (3 with Advanced Degree).
• US FDA or Notified Body Submission experience strongly preferred.
• Knowledge or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s and standards highly desired.
• Knowledge of medical devices preferred.
• Knowledge of digital health, robotics, SaMD, SiMD regulations a plus.
• Familiarity with electronic submission preparation a plus.
• Excellent written and oral communication skills.
• Ability to handle multiple tasks, self-motivate and be detail oriented.
  
  

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.