Johnson & Johnson, Sr Regulatory Affairs Specialist (Remote) - Shockwave - Application via WayUp

WayUp; United States; Remote; USD 89,000 - 144,000; Full time

Job summary

A global leader in healthcare innovation, in partnership with WayUp, seeks a Sr Regulatory Affairs Specialist for a remote role. This position involves ensuring compliance with US and EU regulations, developing regulatory strategies, and supporting product development in the Medical Device sector. With opportunities for performance bonuses and professional growth, this position is ideal for a candidate with strong regulatory compliance knowledge and project management skills.

Benefits

Comprehensive benefits

Performance bonuses

Opportunities for professional growth

Qualifications

• At least 5 years of regulatory affairs experience in the medical device industry.
• Knowledge of US and EU medical device regulations including 510(k), PMA.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Develop submission requirements and regulatory strategies.
• Provide guidance on regulatory compliance for product development.
• Prepare and submit regulatory filings in US, EU, and other geographies.

Skills

Communication

Organizational skills

Regulatory compliance knowledge

Project management

Education

Bachelor's degree

Master’s degree

PhD

Job description

Johnson & Johnson, Sr Regulatory Affairs Specialist (Remote) - Shockwave - Application via WayUp

Join to apply for the Johnson & Johnson, Sr Regulatory Affairs Specialist (Remote) - Shockwave - Application via WayUp role at WayUp.

This role is with Johnson & Johnson. WayUp is partnering with Johnson & Johnson to hire top talent.

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.

Position Overview

The Sr. Regulatory Affairs Specialist is an individual contributor that works closely with internal departments to meet regulatory requirements for Shockwave Medical, Inc. (SWMI). The role involves developing regulatory strategies, ensuring compliance with US and EU regulations, and supporting product development and registration processes.

Key Responsibilities

• Interface with various organizational levels on regulatory matters.
• Develop submission requirements and regulatory strategies.
• Provide guidance on regulatory compliance for product development, quality, and operations.
• Review and approve documentation for submissions.
• Prepare and submit regulatory filings in US, EU, and other geographies.
• Interact with regulatory authorities to facilitate approvals.
• Maintain regulatory files and licenses.
• Support product safety evaluations and recalls as needed.
• Ensure compliance with applicable standards and regulations.
• Manage multiple projects and deadlines efficiently.

Minimum Qualifications

• At least 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree, or 3 years with a Master’s degree, or a PhD without experience.
• Knowledge of US and EU medical device regulations, including 510(k), PMA, EU Technical Files, etc.
• Excellent communication and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Willingness to travel approximately 2-3 times per year.

Additional Information

The salary range for this position is $89,000 - $143,750 outside the Bay Area, and $103,000 - $165,600 in the Bay Area. The role includes comprehensive benefits, performance bonuses, and opportunities for professional growth.

Employment Details

• Employment type: Full-time
• Seniority level: Entry level
• Job function: Regulatory Affairs

Johnson & Johnson is an Equal Opportunity Employer. We value diversity and inclusion and are committed to providing accommodations for applicants with disabilities.