Johnson & Johnson MedTech
Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech
Johnson & Johnson MedTech, Cincinnati, Ohio, United States, 45208
Overview
Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc. role at Johnson & Johnson MedTech. The preferred location for this role is Cincinnati, OH; Santa Clara, CA is also available. This role works a Flex/Hybrid schedule with 3 days per week in-office. There is NO remote option. Relocation assistance may be available on a case-by-case basis. Responsibilities
Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator. Applies strategic regulatory thinking with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. Prepares and submits regulatory information required to obtain global market access, including FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents. Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams, providing expert regulatory feedback for specifications, device testing, risk management, and other documentation for regulatory submission. Proactively identifies issues, communicates timelines for project completion, and addresses complex issues impacting registration status. Conducts regulatory evaluation of changes to devices and generates required regulatory submissions (including Letters To File). Guides conformance with applicable regulations and guidance documents in product development, claims support, labeling, and promotional materials. Assists in the development of Regulatory Affairs processes. Qualifications / Requirements
Minimum of a Bachelor’s Degree required; Advanced Degree highly desired (Science, Engineering, or related field). Minimum 6+ years of related Regulatory Affairs experience within Medical Device required (4+ years with Advanced Degree). Experience with medical device regulatory new product submissions. Track record of developing and driving implementation of regulatory strategies. Working knowledge of how global regulations impact product registration. Good communication skills for effective collaboration with cross-functional partners. Experience collaborating with J&J colleagues globally for strategic contribution and regulatory milestones. Evaluating new regulatory requirements and changes and assessing business impact. Excellent verbal and written communication, attention to detail, and strong analytical/problem-solving skills. High organizational skills with the ability to lead multiple projects simultaneously and prioritize effectively. Ability to present complex regulatory strategies clearly and concisely. Up to 25% travel required. Previous experience with health authority meetings/interactions. Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing documentation in submissions. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. The anticipated base pay range for this position is Cincinnati, OH: $105,000 to $169,050; Bay Area: $121,000 to $194,350. The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus and participates in Company benefit programs including health, retirement, and time-off benefits as described in company materials. For accommodations in the interview process, please contact the Employee Health Support Center or AskGS to be directed to an accommodation resource.
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Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc. role at Johnson & Johnson MedTech. The preferred location for this role is Cincinnati, OH; Santa Clara, CA is also available. This role works a Flex/Hybrid schedule with 3 days per week in-office. There is NO remote option. Relocation assistance may be available on a case-by-case basis. Responsibilities
Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator. Applies strategic regulatory thinking with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. Prepares and submits regulatory information required to obtain global market access, including FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents. Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams, providing expert regulatory feedback for specifications, device testing, risk management, and other documentation for regulatory submission. Proactively identifies issues, communicates timelines for project completion, and addresses complex issues impacting registration status. Conducts regulatory evaluation of changes to devices and generates required regulatory submissions (including Letters To File). Guides conformance with applicable regulations and guidance documents in product development, claims support, labeling, and promotional materials. Assists in the development of Regulatory Affairs processes. Qualifications / Requirements
Minimum of a Bachelor’s Degree required; Advanced Degree highly desired (Science, Engineering, or related field). Minimum 6+ years of related Regulatory Affairs experience within Medical Device required (4+ years with Advanced Degree). Experience with medical device regulatory new product submissions. Track record of developing and driving implementation of regulatory strategies. Working knowledge of how global regulations impact product registration. Good communication skills for effective collaboration with cross-functional partners. Experience collaborating with J&J colleagues globally for strategic contribution and regulatory milestones. Evaluating new regulatory requirements and changes and assessing business impact. Excellent verbal and written communication, attention to detail, and strong analytical/problem-solving skills. High organizational skills with the ability to lead multiple projects simultaneously and prioritize effectively. Ability to present complex regulatory strategies clearly and concisely. Up to 25% travel required. Previous experience with health authority meetings/interactions. Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing documentation in submissions. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. The anticipated base pay range for this position is Cincinnati, OH: $105,000 to $169,050; Bay Area: $121,000 to $194,350. The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus and participates in Company benefit programs including health, retirement, and time-off benefits as described in company materials. For accommodations in the interview process, please contact the Employee Health Support Center or AskGS to be directed to an accommodation resource.
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