Senior Regulatory Affairs Specialist Job at ACE Partners, Union City, CA

K1ArQ0x5czhFMlkybkEvcTVIWUNHN0V2
  • ACE Partners
  • Union City, CA

Job Description

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.

Job Tags

Similar Jobs

Allied Mineral Products, LLC

OFFICE ADMINISTRATOR Job at Allied Mineral Products, LLC

 ...looking for a Office Administrator to provide support to senior managers and perform administrative duties. He/...  ...managers in the smooth and efficient running of the business and timely support to executives. Employment Type: Part-Time Salary: $ 35.00 Per Hour

Galt House Hotel

Front Desk Agent - All Shifts Job at Galt House Hotel

 ...Front Desk Attendant Employee Perks! Same Day Pay Access, FREE Parking...  ..., Shoes for Crews Discounts, Hotel Room Discounts at Various...  ...searching for our 1st and 2nd shift front desk attendant opportunities...  ...availability: Day Shift (Preferred) Night Shift (Preferred) Job Types:... 

Envoy

Data Analyst Intern Job at Envoy

 ...communicate openly, stand out, pitch in, and choose action. As an intern at Envoy, you will work as an indispensable part of a team while...  ...events Internship Schedule and Duration ~12 - 14 weeks ~ Summer, fall, or winter ~ Applications will be accepted and evaluated... 

Webster Bank

Analyst, Compensation Job at Webster Bank

 ...analytical professional to join our Human Resources team as an Analyst, Compensation. This role will support key compensation activities...  .../banking industry~Experience working with MarketPay and WorkdayThe estimated salary range for this position is $80,000USD... 

MalaceHR

Custodian Job at MalaceHR

 ...Seeking Custodians and Trash Technicians for logistics facility in Spokane, WA Composite or steel-toe shoes/boots required Days-$17.00/hour Shifts: Schedules General Cleaners/Trash Technicians Monday-Friday, 5a--1:30p, full-time Friday/Saturday,...