Associate Director, Regulatory Affairs Global Strategy & Implementation.

仕事内容

Ethicon Inc., a Johnson & Johnson company, is recruiting for an Associate Director, Regulatory Affairs Global Strategy & Implementation located in Raritan, New Jersey; Cincinnati, Ohio; Norderstedt, Germany; Livingston, UK; Pinewood, UK; Beijing, China; other J&J Ethicon sites may be considered.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 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 and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

An exciting opportunity has arisen for an Associate Director Regulatory Affairs, Global Strategy & Implementation at Ethicon, a Johnson & Johnson Company. This role ensures the regulatory environment of global markets is understood by the organization. Developing and implementing assessments of the impact of new and changing regulations on the business’ research and development programs to assure timely commercialization of products in compliance with applicable regulations. Leading a team to deliver strategies for launches, regulatory change and authority and legal requests. Your ability to build and maintain strong relationships with internal and external local, regional, and global business key partners, including Notified Bodies, Competent Authorities and Trade Associations will be critical.

• Responsible for developing and implementing regulatory strategies to prepare the business for regulatory change impacting innovation, life-cycle, and compliance activities across the platform.
• Influencing all areas of the business and applying strong regulatory leadership to drive solutions to implementation for the regulation and upcoming secondary legislation.
• Delivers on strategies for acquiring and maintaining regional approval of products (e.g. CE-marking of new products and maintaining products on the market).
• Responsibility for the liaisons to regulatory authorities (e.g. key notified bodies and others authorities); collaborate with the policy organization on strategies and shaping opportunities
• Accountability for partnering closely with internal partners (including Marketing & R&D Leaders, Regional Leads, Clinical and Medical Affairs) to ensure that the partners’ voices are evaluated within the strategies.
• Responsibility for driving applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures.
  
  

Education

Qualifications

• Bachelor’s degree required; Advanced degree is preferred
  
  

Required Experience And Skills

• A minimum of 8 years of global, large, healthcare products industry or closely related experience
• Previous experience with medical device and/or pharmaceutical regulations and international regulatory experience to maintain legal status of products and minimize risk
• Consistent track record of leading complex cross-sector or enterprise/company-wide initiatives, and representing the function during cross-functional or leadership discussion
• Proven track record of leadership success
• Consistent record of strategic planning and ability to partner and influence cross-functional department partners
• A strong results-orientation and effective communication with a diverse clientele base
• Experience working collaboratively with coworkers and external partners
  
  

Preferred Experience And Skills

• Experience with the preparation, submission, and approval of regulatory documentation for medical devices
• Experience leading and developing people
• Experience driving strategic change to meet changing business needs, and exploring new opportunities using multiple insights for achieving business objectives
• Demonstrated knowledge and expertise in bridging technical and business subject areas, data-driven decision making and quantitative analysis skills to drive business results
• Skilled in communicating complex ideas clearly and concisely, and able to challenge others to think through problems, improvement opportunities, solutions, and plans
• Expert project management skills (leading projects)
  
  

Other

• Up to 10-20% domestic/international travel may be required
  
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

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

United States-New Jersey-Raritan-1000 US HIghway 202

Other Locations

Europe/Middle East/Africa-United Kingdom-Scotland-Livingston, Europe/Middle East/Africa-Germany-Schleswig Holstein-Norderstedt, North America-United States-Ohio-Cincinnati, North America-United States, Asia Pacific-China-Beijing, United Kingdom-England-Wokingham

Organization

Ethicon Endo Surgery Inc (6041)

Job Function

Regulatory Affairs

Requisition ID

2206038925W