Regulatory Affairs Specialist Johnson & Johnson – Switzerland & United States

Johnson & Johnson; Philadelphia (Philadelphia County); Hybrid; USD 74,000 - 120,000; Full time

Job summary

Join a forward-thinking company as a Regulatory Affairs Specialist, where you will play a pivotal role in ensuring compliance and facilitating product launches. This dynamic position requires a proactive individual with a strong background in regulatory affairs, focusing on strategic planning and submissions. You will collaborate closely with product development teams, providing essential regulatory guidance and ensuring that all products meet the necessary standards. With a competitive compensation package and a commitment to employee well-being, this role offers a unique opportunity to make a significant impact in the healthcare industry.

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Performance-based bonus

Vacation time

Sick leave

Holiday pay

Life insurance

Disability insurance

Qualifications

• 2-4 years of regulatory affairs experience required.
• RAC certification for Medical Devices preferred.

Responsibilities

• Ensure compliance with regulatory agency regulations.
• Prepare responses to regulatory agencies' questions.
• Provide regulatory guidance to product development teams.

Skills

Regulatory compliance

Risk-benefit analysis

Organizational skills

Problem-solving

Education

Bachelor's degree

Tools

Regulatory agency guidelines

Medical device standards

Job description

Job Title: Regulatory Affairs Specialist

Company: Johnson & Johnson

Location: Switzerland & United States

Job Code: 2406227711W

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. 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.

Position Overview:

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:

1. Ensures compliance with regulatory agency regulations and interpretations.
2. Prepares responses to regulatory agencies' questions and other correspondence.
3. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
4. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
5. Provides solutions to a variety of problems of moderate scope and complexity.
6. Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals.
7. Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance.
8. Provides regulatory guidance to product development teams and responds to product information requests.

Qualifications:

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

Compensation and Benefits:

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. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

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:

o Vacation – up to 120 hours per calendar year

o 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

o Holiday pay, including Floating Holidays – up to 13 days per calendar year

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.