Compliance Manager

Description

The Compliance Manager oversees daily operations to ensure the organization meets its compliance objectives by monitoring policies, interpreting regulatory developments, and providing strategic recommendations. This role leads change management initiatives, collaborates with departments to ensure adherence to legal and regulatory standards, and serves as a subject matter expert for key projects. Responsibilities include managing internal and external audits, supporting regulatory assessments, driving sustainability and ESG initiatives, and engaging stakeholders through training and continuous improvement efforts to maintain compliance and support business goals.

Requirements

Key Job Responsibilities:

• Manage the daily activities of the Compliance Department to meet established goals and objectives. Provide ad-hoc support to compliance team members on initiatives across the elements of compliance.  
• Interpret regulatory developments and industry trends, providing insights and recommendations to enhance compliance strategy, and its impact on the organization.
• Monitors current policies, laws, and regulations, and notifies others, so there is no ambiguity in the compliance and represents as SME for key projects.
• Lead change management efforts related to compliance initiatives, including stakeholder engagement, communications, and training.  
• Work with each department within the organization to ensure compliance with the company's corporate electronic Quality Management System (eQMS).
• Responsible for all internal and external audits. Organize, participate, and collaborate with customers, 3rd parties, and regulatory bodies in setting up audits. Management of the overall auditing process, including closure of audits with corrective actions. 
• Assist customers with regulatory assessments, and inquiries, and conduct external research as needed.
• Organize, manage, and submit Sustainability and ESG materiality assessments and stakeholder engagement reviews.
• Effectively collaborates with departments (i.e. Engineering, Manufacturing, Supply Chain) on various projects/improvements when input/participation from Compliance is needed.
• Other duties as assigned and required to support the business objectives. Support all sites as needed and directed with the above activities.

Education, Skills and Experience Requirements:

• A Bachelor's degree is required in Science or a related field 
• Advanced degree or certification is a plus, specifically in healthcare compliance, law, or business.  
•  5 years of previous experience in a Compliance leadership role is required for this position, previous life sciences or med device experience is strongly preferred
• Knowledge of FDA, EMA, ASEAN, ECHA, compliance regulations, laws, and standards. 
• Working knowledge of REACH, RoHs, ISO 9001, ISO 14001, ISO 45001, ISO 13485, and other industry regulatory knowledge are highly desired.  
• Knowledge of ESG ratings and indices. Knowledge of initiatives such as the Task Force on Climate-Related Disclosures, Sustainable Development Goals and the Value Reporting Foundation
• Computer skills and proficiency with Microsoft Office software, Hubspot, etc..
• Excellent organization skills. Ability to handle multiple priorities. Attention to detail is a must.
• Ability to communicate effectively with all levels of the organization and with outside partners.
• Demonstrated ability to set priorities, meet deadlines, and deliver commitments on time in a fast-paced environment.
• Ability to handle high-stress situations.