Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- Regulatory Compliance Specialist ensuring compliance with federal and state regulations for Gift of Life Michigan. Collaborating with teams to support policy implementation and risk mitigation.
Responsibilities
- Monitor, interpret, and communicate regulatory changes from agencies such as CMS, FDA, OPTN, HRSA, OSHA
- Develop, update, and maintain internal policies, procedures, and guidelines for designated clinical and administrative areas
- Collaborate with clinical, administrative, and operational teams to support policy implementation and risk mitigation
- Complete compliance forms and reports for regulatory agencies
- Support internal audits and quality management system activities
Requirements
- Bachelor’s degree in health policy, healthcare administration, public health, business administration, or a related field
- 3 years’ experience in compliance, regulatory affairs, or policy analysis
- Familiarity with health regulations and standards (e.g., FDA 21 CFR Part 1271, HIPAA, OSHA, AATB, AOPO, OPTN)
- Strong writing and research skills; ability to interpret complex regulations and translate them into actional policies.
- Written and verbal fluency in English
Benefits
- Health insurance
- 401(k) retirement plan
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Corporate Compliance Clerk supporting Business Law team in London, Ontario, maintaining minute books and preparing corporate documentation. Requires 3+ years' experience and offers a hybrid work arrangement.
Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.
Senior Consultant managing Compliance projects in the medical devices sector with a focus on Quality & Regulatory. Collaborating with a dynamic team in a leading GMP - expert company.
Senior Project Engineer focusing on GMP Compliance in the Life Sciences sector. Responsible for project planning, execution, and client communication in Mannheim, Germany.
Consultant for GMP compliance and quality assurance in Life Sciences. Engage in validation projects and assist in compliance documentation.
Regulatory CMC Manager supporting multi - product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.
Manage Vodafone's satellite communications policy and regulations while collaborating with teams. Engage in strategic initiatives and develop regulations to support satellite ambitions.
Compliance Analyst managing fraud prevention strategies and governance in Brazil's iGaming sector. Ensuring compliance with regulations and internal policies in a dynamic environment.