Compliance Lead for Electrification Systems’ Channel Partner portfolio in Asia, partnering with regional and business compliance leaders and teams to support compliance objectives.
About the role
- Senior Regulatory Affairs Specialist ensuring compliance in medical devices for international markets. Collaborating with cross-functional teams for regulatory submissions and product approvals.
Responsibilities
- Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
- Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
- Compile and submit documentation as required in support of marketing initiatives.
- Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).
Requirements
- 5+ years of regulatory medical device industry experience.
- RAC Certification preferred.
- Knowledge of regulatory guidelines and requirements (domestic and international).
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
EHS Governance Manager supporting Regions globally in compliance and risk management for Project, Services, and Manufacturing activities. Ensuring governance and transparency in operations across industrial or energy environments.
Working student supporting Trade Compliance Data Platform at BASF in data modeling and analysis. Involves structuring data, working with SAP and creating SQL queries.
Compliance Engineer ensuring safety and assurance at high - hazard operations for Babcock. Supporting national security and engineering excellence at HMNB Clyde Faslane with compliance monitoring.
Compliance Lead managing Electrification Systems’ Channel Partner compliance in Asia. Collaborating with Compliance Leaders and teams to enhance regional compliance objectives.
Senior Manager, Operations Compliance at Equinix managing EHS compliance across AMER operations. Leading audits, risk management, and ensuring safety in the workplace.
Manager overseeing licensing and regulatory compliance for Pharmacy Benefit Dimensions. Responsible for operational activities and ensuring adherence to quality management and accreditation standards.
Risk and Compliance Manager overseeing third - party risk control and compliance in finance. Collaborating with teams across different locations to establish effective risk management strategies.
Senior Airworthiness Specialist at Boeing's CASO ensuring safety and excellence in aerospace. Involves certification activities on 737 MAX development programs with industry professionals.
Compliance Manager/Senior Manager handling income tax compliance aspects for high - net - worth individuals at Deloitte. Building client relationships and mentoring team members in tax legislation compliance.