Regulatory Affairs Specialist Johnson

Description:

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/.

Regulatory Affairs Specialist II Johnson & Johnson – Switzerland & United States

Are you ready to take your career in Regulatory Affairs to the next level and make a significant impact? Join our dynamic team at Johnson & Johnson, where your expertise will play a crucial role in ensuring our innovative products meet the highest standards of safety, efficacy, and compliance.

This role will work a Flex/Hybrid schedule and must be based in Switzerland, Zuchwil or within a commutable distance of US, Raynham or West Chester. There is no remote option.

This position requires an independent and proactive individual who will provide regulatory guidance in strategic planning, pre-marketing activities, and related submissions to facilitate timely new and modified product launches.

Objectives of the Position

• 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.
• Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches, 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.
• Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance.
• Provides regulatory guidance to product development teams and responds to product information requests.

Qualifications:

• A minimum of a Bachelor's degree is required.
• 2-4 years of regulatory affairs or related/equivalent experience is required.
• Experience within Biological Medical Devices is meriting.
• RAC certification for Medical Devices preferred.

What You Will Need To Succeed

We are looking for a dedicated and detail-oriented individual to join our team. The ideal candidate will possess excellent organizational skills and the ability to manage multiple tasks effectively. A key component of this role will involve applying risk-benefit analysis techniques to inform decision-making.

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.

The anticipated base pay range for this position is $74,000 to $119,600 based on experience. 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.

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 identity, 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.

Application

If you are interested in this position, please apply with an updated CV and Cover letter. Please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.

If you have issues applying, please use Chrome Web Browser and reset your password. If that does not help you can get more guidance and contact us from this page: https://www.careers.jnj.com/contactus-faq.