Regulatory Affairs Specialist 1

Description:

Johnson & Johnson is currently seeking a Regulatory Specialist 1 to join our MedTech Vision Team located in Jacksonville, Florida.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Primary responsibilities include support and assistance in preparation, submission, and maintenance of global regulatory documents/dossiers under direct supervision.

Key Responsibilities:

• Provides assistance in preparation, compilation, and submission of global regulatory dossiers, US and International for new and existing products.
• Researches and collects information and data to support periodic reports to regulatory agencies in support of international product registrations. Ensures that Regulatory Impact Assessments for product, process and package changes are completed and the results communicated to the appropriate departments.
• Coordinates and assists in the maintenance of licenses and authorizations for existing products (US IRB, US PMA, International registrations and dossiers, updates to DOC (technical files), engineering and device change requests.
• Participates in cross-functional project teams (as needed).
• Coordinates and assists in the review and approval of new and/or revised product labeling to ensure regulatory compliance.
• Provides Regulatory Affairs support during internal and external audits (as needed).
• Adheres to environmental policy and procedures and supports department environmental objectives.
• Ensures the regulatory information management system is used as intended to enable accurate and complete global product and license data.
• Assists with department budget activities and tracking of spend.
• Completes regulatory process improvement activities (as needed).
  
  

Qualifications:

Education:

• BS degree or equivalent experience (scientific field preferred)
  
  

Required:

• Strong attention to detail and time management skills
• Effective written and verbal communication skills, including with people with different cultures or where English is not their first language
• Ability to work independently, be proactive and resourceful when looking for guidance
• Problem-solving capability, including trouble shooting and adaptability required
• Awareness of interdependencies and ability to collaborate cross-functionally
• Proficient with Adobe Acrobat, MS Word, Excel and PowerPoint
  
  

Preferred:

• Technical ability to efficiently operate in electronic systems is preferred.
  
  

This job posting is anticipated to close on July 25, 2024, the company may however extend this time-period.

The anticipated base pay range for this position is $57,000-$92,000. 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
  
  

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market