PhiladelphiaRecruiter Since 2001
the smart solution for Philadelphia jobs

Associate Director, Regulatory Affairs - Ethicon, Inc

Company: Johnson & Johnson
Location: Philadelphia
Posted on: November 20, 2023

Job Description:

Job Description - Associate Director, Regulatory Affairs - Ethicon, Inc. (2306151725W) Associate Director, Regulatory Affairs - Ethicon, Inc. - 2306151725W Description Ethicon, Inc., a member of Johnson & Johnson Family of Companies, is currently recruiting for an Associate Director, Regulatory Affairs.The preferred location for this role is Raritan, NJ however remote options in the Eastern United States or Western Europe will be considered on a case-by-case basis. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products, and services to advance the health and well-being of people. With $82.5 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 260 Johnson & Johnson operating companies employing over 135,000 people, who help deliver products that touch the lives of over a billion people every day throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Johnson & Johnson Medical Devices is focused on shaping the future of surgery with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery. -Ethicon, Inc., part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit - . OVERALL RESPONSIBILITIES: The Associate Director, Regulatory Affairs for Ethicon's Biosurgery business unit will be responsible for partnering with R&D and Global Strategic Marketing platform leaders as well as other cross-functional team members/leaders to develop and execute global regulatory strategies to drive pipeline development and global launch excellence.Products supported are considered significant-risk medical devices worldwide to address a range of surgical challenges related to sealing and bleeding (e.g., Class II and Class III devices in the US).This role may also support combination product strategy (i.e., biologics/medical device) in a limited capacity.Primary responsibilities will include the development and execution of regulatory strategies to obtain market access for new/modified products and lifecycle management activities required to maintain existing products globally.The Associate Director is also responsible for evaluating the impact of current and emerging standards and regulations and determining the most effective and efficient strategies for obtaining or maintaining product clearances/approvals/registrations in key markets. POSITION DUTIES & RESPONSIBILITIES: - Act as a strategic partner with colleagues in R&D, Preclinical Research, Clinical Development, Global Strategic Marketing, Supply Chain, and Health Economics Market Access teams to develop and execute global regulatory strategies for new and existing products to assure on-time regulatory approval/clearance and post-marketing activities with a focus on strategic markets. - Leverage a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products. - Develop and submit US and EU regulatory filings such as Pre-submissions, IDEs, PMAs, 510ks, and Design Dossier/Technical Files. Partner with regional leaders on regulatory strategy and submissions to successfully obtain marketing approvals for all other markets. - Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings. - Partner with regional leaders and the Regulatory Affairs Policy Intelligence team to monitor the regulatory environment globally and assess and communicate the impact of current and emerging regulations on the company's portfolio of products, define the future vision, and drive innovative thinking. - Integrate large amounts of changing, complex, and/or ambiguous information for effective decision-making and clearly communicate complex issues and solutions to stakeholders to achieve strategic and/or project goals. - Review product design, labeling, and manufacturing changes to existing products to assess the impact to safety and efficacy. - Collaborate with Legal and Quality partners regarding product safety and quality issues. Contribute to risk management plans and failure mode analysis during product development and safety signal detection and post- market surveillance post-launch. - Apply Regulatory knowledge of competitor products, strategies, and market segmentation to help identify opportunities and potential Regulatory challenges. - Manage, oversee and balance resource allocation across critical projects. - Provide key input for product claims and evidence support, and review and approve Advertising and Promotional materials in accordance with local regulations. - Lead, inspire, and coach RA staff members, directly or indirectly. - Influence and collaborate to bring about process and technical improvements within the organization. - Represent the company and influence regulations and health authority guidance through industry trade association(s) in partnership with the Policy Intelligence team. - Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements. The base pay range for this position is $140,000 to $225,000 based on experience.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Qualifications EDUCATION & EXPERIENCE REQUIREMENTS:

  • Bachelor's degree is required. Advanced degree is a plus. Degree in a technical related discipline is preferred.
  • Minimum 10 years relevant regulated industry experience is required or 7 years with an advanced degree.
  • Previous experience with medium and high-risk medical devices (including regulatory submissions) is strongly preferred. Previous experience with combination product is a plus.
  • Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
  • Experience working closely with and negotiating with Health Authorities (FDA/EU) is preferred.
  • Experience working with professional and trade associations is a plus. 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. Primary Location NA-US-New Jersey-Raritan Other Locations Europe/Middle East/Africa-United Kingdom, NA-US-New Jersey, NA-US-New York, NA-US-Georgia, NA-US-Massachusetts, NA-US-Pennsylvania, NA-US-South Carolina, NA-US-Ohio, Europe/Middle East/Africa-Ireland, NA-US-Maryland, Europe/Middle East/Africa-France, NA-US-Florida, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Belgium, NA-US-North Carolina, NA-US-Virginia, NA-US-Maine, NA-US-Rhode Island, NA-US-Connecticut Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement. If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services,Inc.with any questions or search this site for more information.Privacy Policy Privacy Policy Legal Notice News Investor Contact Us

Keywords: Johnson & Johnson, Philadelphia , Associate Director, Regulatory Affairs - Ethicon, Inc, Executive , Philadelphia, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Philadelphia RSS job feeds