[Hiring] Senior Regulatory Affairs Specialist @Johnson & Johnson Innovative Medicine

Role 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. 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.
• Provides Regulatory Affairs support during internal and external audits and assists in leading the development of best practices for Regulatory Affairs.
• Represents Regulatory Affairs on cross-functional project teams.

Qualifications

• Minimum of a Bachelor's Degree from an accredited college or university is required; Advanced Degree strongly preferred.
• 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 required.

Requirements

• 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

Benefits

• 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)).
• 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 period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.