Medical Device Business Services, part of Johnson & Johnson MedTech, is recruiting for a Regulatory Affairs Specialist II to support the Digital PWT AES regulatory affairs organization. This role will work a Flex/Hybrid schedule and must be located within a commutable distance of Palm Beach Gardens, FL. There is NO remote option.
About Johnson & Johnson
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The Regulatory Affairs Specialist II provides regulatory guidance to project teams in business planning and related submissions to support DePuy Synthes Digital PWT AES products. Under minimal direction, the individual develops and performs regulatory strategies for significant change supplements and 510(k) registrations to support the continued commercialization of products in key countries. This role helps define the data and information needed for regulatory actions in conjunction with cross-functional teams. In addition, this candidate guides conformance with applicable regulations through the development of standard methodologies for Regulatory Affairs processes, procedures and systems.
Key Responsibilities:
• Prepares responses to regulatory agencies' questions and other correspondence.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Researches and collects data and responds to requests from regulatory agencies and/or distributers to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
• Advises on regulatory labelling requirements and specifications for modified products and reviews product labelling to ensure compliance.
• Provides regulatory guidance and mentorship to project teams and responds to product information requests.
• Provides regulatory affairs support during internal and external audits.
• Assists in the development of standard methodologies for Regulatory Affairs processes.
• Responsible for communicating business related issues or opportunities to the next management level and represents Regulatory affairs on cross-functional project teams.
• Responsible for following all company guidelines related to health, safety and environmental practices, as applicable.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies and procedures.
Qualifications
Minimum Qualifications:
• Minimum of a Bachelor's Degree is required; an Advanced Degree is strongly preferred. Desired fields of study include Biomedical Engineering, medical/scientific writing, or other Engineering focus.
• At least 3+ years of regulatory affairs or related/equivalent experience in the Medical Device sector.
• Experience with U.S. FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) is required.
• Demonstrated expertise in medical device regulatory requirements and processes.
• Outstanding project management skills, as demonstrated by competence in leading multiple projects simultaneously.
• Outstanding written and oral communication skills.
• Experience in worldwide regulatory systems is preferred.
• Previous medical device submission experience is preferred.
• Demonstrated expertise in orthopedics and orthopedic device regulatory requirements is preferred.
• Up to 10% domestic or international travel may be required.
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 identify, 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
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