Senior Regulatory Affairs Specialist

ACE Partners; Union City (CA); On-site; USD 100,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies and submissions for innovative medical devices. This role involves managing product approvals globally, mentoring junior staff, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to navigate complex regulatory landscapes, making a significant impact on product success. If you have a passion for regulatory affairs and a desire to empower the next generation of vascular MedTech, this opportunity is perfect for you.

Benefits

Medical Insurance

Vision Insurance

401(k)

Qualifications

• 4+ years of regulatory experience with FDA Class II/III or EU Class IIb/III devices.
• Strong project management and communication skills.

Responsibilities

• Develop regulatory strategies and manage submissions for product approvals.
• Collaborate with global teams to ensure compliance and address queries.

Skills

Regulatory Strategy Development

Project Management

Communication Skills

Collaboration Skills

Regulatory Compliance

Education

Bachelor's Degree

Advanced Degree

Tools

Regulatory Submission Tools

Quality Management Systems

Job description

This range is provided by ACE Partners . Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100,000.00/yr - $120,000.00/yr

Direct message the job poster from ACE Partners

Empowering the Next Generation of Vascular MedTech

Position Objective:

The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, managing submissions, and securing product approvals globally. They also assess regulatory impacts of device changes and mentor junior staff.

Key Responsibilities:

• Develop regulatory strategies and submissions (e.g., 510(k), IDE, EU/CE, international registrations).
• Collaborate with global teams to ensure compliance and address regulatory queries.
• Review and negotiate product submissions for timely approvals.
• Support marketed products, including labeling and promotional material reviews.
• Assist with regulatory compliance, registrations, and audits.
• Maintain global regulatory knowledge and relationships with agencies.
• Guide junior staff and ensure adherence to quality systems.
• Experience with Cybersecurity, Wireless or Sterilization

Qualifications:

• Bachelor’s degree with 4+ years of regulatory experience, or an advanced degree with 2+ years.
• Experience with FDA Class II/III or EU Class IIb/III devices.
• Strong project management, communication, and collaboration skills.
• Ability to manage multiple tasks and lead regulatory projects.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal and Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at ACE Partners by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified about new Regulatory Affairs Specialist jobs in Union City, CA.

San Jose, CA $80,000.00-$90,000.00 2 months ago

Regulatory Affairs Specialist - (NMPA/CFDA)

Union City, CA $100,000.00-$120,000.00 2 weeks ago

Associate /Senior Associate, Regulatory Affairs – Regulatory Operations

Alameda County, CA $100,000.00-$130,000.00 2 weeks ago

Staff Regulatory Affairs Specialist - Hybrid

Alameda, CA $86,700.00-$173,300.00 1 month ago

Principal Regulatory Affairs Specialist (Remote) - Shockwave

Sunnyvale, CA $97,000.00-$139,000.00 6 days ago

Sr. Regulatory Affairs Specialist - Medical Devices

Union City, CA $100,000.00-$120,000.00 2 days ago

Fremont, CA $85,000.00-$90,000.00 4 days ago

Principal Regulatory Affairs Specialist (Business Partnerships).

Pleasanton, CA $130,000.00-$160,000.00 1 month ago

Principal Regulatory Affairs Specialist – US New Product Introduction – Diabetes Care (on-site)

Alameda, CA $98,000.00-$196,000.00 5 months ago

Manager, Regulatory Affairs- Body Contouring

Sr. Regulatory Operations Specialist (Remote) - Shockwave

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.