Regulatory Affairs Specialist II (Orthopedics PWT AES) - Medical Device Business Services, Inc

Description:

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. The preferred location for this role is within a commutable distance of Palm Beach Gardens, FL however candidates located near Raynham, MA, West Chester, PA, and Warsaw, IN will also be considered. This role will work a Flex/Hybrid schedule with 3 days per week in office, there is NO remote option.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

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

The anticipated base pay range for this position is $74,000 to $119,600. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
  
  

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits