Principal Regulatory Affairs Specialist (Remote) - Shockwave

Jnjmedtech; Santa Clara (CA); Remote; USD 90,000 - 150,000; Full time

Job summary

An innovative company is seeking a Principal Regulatory Affairs Specialist to ensure compliance and develop strategies for medical devices. This remote role involves preparing submissions, interacting with regulatory agencies, and ensuring adherence to international standards. With a focus on product safety and compliance, this position offers a competitive salary and comprehensive benefits. Join a forward-thinking team and make a significant impact in the medical technology field.

Qualifications

• 8-10 years of regulatory experience in medical devices.
• Strong knowledge of global regulatory guidelines.

Responsibilities

• Develop regulatory policies and strategies.
• Prepare and submit regulatory documentation to authorities.
• Ensure compliance with ISO, IEC, and FDA regulations.

Skills

Regulatory Affairs

Compliance with ISO and FDA regulations

Negotiation with regulatory agencies

Documentation preparation

Education

Degree in a relevant scientific or technical field

Tools

MS Office

Job description

Principal Regulatory Affairs Specialist (Remote) - Shockwave

Join to apply for the Principal Regulatory Affairs Specialist (Remote) - Shockwave role at Johnson & Johnson MedTech.

This position involves working closely with internal teams to meet regulatory requirements for Shockwave Medical Inc., including developing strategies, preparing submissions, and ensuring compliance with international standards and regulations. The role requires a minimum of 8-10 years of related experience, preferably in medical devices, with strong knowledge of global regulatory guidelines.

Key responsibilities include:

1. Developing regulatory policies and strategies.
2. Preparing and submitting regulatory documentation to authorities worldwide.
3. Interacting with regulatory agencies and negotiating approvals.
4. Ensuring compliance with standards such as ISO, IEC, and FDA regulations.
5. Supporting product safety, recalls, and labeling compliance.

Qualifications include a degree in a relevant scientific or technical field, extensive regulatory experience in medical devices, and proficiency in MS Office. The role offers competitive salary ranges based on location, along with comprehensive benefits.