Full Job Description
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Remote (US)
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Wound Closure and Healing group. Preference will be given to candidates located within a commutable distance of Raritan, NJ however remote work options will be considered on a case by case basis and if approved by the company.
Purpose: The Senior Regulatory Affairs Specialist (Regulatory Affairs Specialist III) provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Wound Closure & Healing (WCH) products. Under minimal supervision, the individual is responsible for developing and executing global regulatory strategies to support new, modified and currently marketed medical devices. This includes the preparation of regulatory documentation for submissions to regulatory health authorities (i.e. European Notified Body, BSI, European MDR, and FDA). He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Specialist III helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures, and systems.
You will be responsible for:
• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares responses to regulatory agencies' questions and other correspondence.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
• Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance.
• Provides regulatory guidance to project teams and responds to product information requests.
• Provide Regulatory Affairs support during internal and external audits and assists in leading the development best practices for Regulatory Affairs.
• Represents Regulatory Affairs on cross-functional project teams.
Functional and Technical Competencies:
• Leverages scientific and technical understanding of regulated products within the scope of responsibility to provide regulatory input to product development and lifecycle management and evaluate regulatory impact on products.
• Contributes to the development and execution of effective, results-oriented regulatory strategies aligned with business objectives, focusing on the priorities that matter most for patients and the business.
• Evaluates available facts, benefits, risks, and Credo considerations to support sound decisions, seeking guidance as appropriate in ambiguous or unclear situations.
• Supports complex projects and delivers with discipline and accountability by establishing clear priorities, using facts to solve problems, and making timely and effective decisions to execute project deliverables.
• Brings relevant external, customer, and regulatory perspectives into the work and collaborates effectively across functions and levels to develop solutions and advance regulatory objectives.
• Identifies opportunities to improve and simplify regulatory ways of working while maintaining appropriate controls and compliance requirements.
• Demonstrates continuous learning and communicates openly, directly, and constructively to support effective decisions, problem-solving, and execution. Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver business results.
Qualifications / Requirements:
• Minimum of a Bachelors Degree from accredited college or university is required, Advanced Degree strongly preferred. Science, biomedical engineering, medical / scientific writing, public health administration field of study desired.
• At least 4+ years of regulatory affairs or related/equivalent experience (2+ with Advanced Degree) is required.
• Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations is required.
• Knowledge of US and OUS health products regulations is preferred.
• Previous medical device submission experience is preferred.
• Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes.
• Ability to communicate clearly and accurately, both verbally and in writing, to a widely varied audience.
• Ability to work well under deadlines.
• Excellent written and communication skills, fluency in English.
• Good judgement/decision making and problem-solving ability, capable of understanding the impact of decision making.
• Motivated and an enthusiastic self-starter with the ability to work under own initiatives and as a team player.
• The position is preferred to be located in Raritan, NJ or can be remote in the United States for the right candidate with up to 10% travel is required.
#LI-Remote
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is :
$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
