Associate Director, Regulatory Affairs (Instruments & Accessories) - Robotics & Digital Solutions, Inc. - 2406195848W

Description

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for an Associate Director, Regulatory Affairs to support our Instruments and Accessories portfolio. This role will be based in Cincinnati, OH and will work a Flex/Hybrid schedule with 3 days per week in office . Relocation assistance may be available to qualified candidates.

About Johnson & Johnson

At 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/.

In joining our growing regulatory team, the Associate Director will help Ethicon reach US and international regulatory (NPD) approval goals. You will be responsible for our instruments and accessories portfolio development RA needs, working closely with a fast pace exceptional engineering and clinical teams, as well as supporting product development stages and generating submission ready documentation and authoring regulatory submissions. Additionally, this individual will support health authority communications and contribute to strategy development. This position reports to the Director of Regulatory Affairs.

Key Responsibilities :

• Manage instruments and accessories regulatory team

• Define regulatory strategy for devices and gather necessary intel to inform the strategy and ensure compliance

• Manage preparation of regulatory submissions required for device approvals and registrations in the US and globally, including health authority meetings. Duties include preparation of and with cross-functional team towards the goals the project.

• Provide regulatory functional leadership to R&D organization and crossfunctional partners for assigned portfolio. Collaborate with J&J colleagues globally to support regulatory milestones.

• Provide regulatory expertise to other cross-functional teams on NPD & LCM project teams through design control, V&V, and implementation of regulatory strategy. This includes conducting reviews and providing regulatory feedback for specifications, device testing, labeling, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.

• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File).

• Support preparation of labeling materials in collaboration with cross-functional teams, e.g. Tech publishing, Engineering, Clinical Development.

• Support research personnel, application specialists, and risk management specialists, to ensure clinical research and clinical evaluation are performed in accordance with regulatory requirements.

• Support preparation of materials, reports and follow-up with Regulatory Agencies regarding recall activity.

• Prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.

• Support quality system and technical file/design dossier audits.

• Other duties as assigned.

Qualifications

Required Qualifications :

• Minimum of a Bachelor's Degree is required , Advanced Degree strongly preferred ; Science, Engineering, or related discipline desired.

• Minimum 10 years of regulatory experience in a medical device development with strong independent regulatory submissions development experience.

• Experience leading teams with direct reports professional development and guidance.

• Strong working knowledge of U.S. FDA medical device regulations and guidances.

• Proven track record clearing medical devices to market in the US and internationally.

• Technical experience with biocompatibility, sterilization, reprocessing of medical devices.

• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and knowledge ISO 14971.

• Solid understanding of IEC 60601 series preferred .

• Familiarity with international regulations and guidance medical device market including clearance/approvals of new devices and changes to devices (such as Europe, China, Brazil, Japan, etc.) preferred .

• Experience with medical device software and coverage of software in submissions preferred .

• Excellent verbal and written communication skills; strong attention to detail.

• Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks.

• Proven ability to articulate customer needs and feedback to the engineering and marketing organizations.

• Strong learning skills for complex technology and presentation skills to be able to present complex technology in clear, concise, and comprehensive fashion.

• Advanced analytical and problem-solving skills.

• Ability to translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements.

• Approachable individual who provides a high level of teamwork and cross-functional collaboration.

• This position is located in Cincinnati and will require up to 20% 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.

Primary Location NA-US-Ohio-Cincinnati

Organization Auris Health, Inc. (6267)

Job Function Regulatory Affairs

Req ID: 2406195848W