Quality Compliance Manager overseeing compliance implementation and project management in medical device industry. Strong experience in Quality Management Systems and cross - functional collaboration is required.
About the role
- Providing regulatory support and guidance for global and US device product registrations at ICU Medical. Assuring compliance and assisting in registration strategies and document maintenance.
Responsibilities
- Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables.
- With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers.
- Assures full regulatory compliance of all documentation for submissions and change management.
- Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
- Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
- With oversight, understand and respond to regulatory agency correspondence.
- Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
- Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
Requirements
- Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- RAC Certification preferred
- A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
- Able to assess scientific arguments and apply analytical and logical reasonings.
- Ability to effectively prioritize workload and multitask with minimal supervision.
- Good interpersonal skills.
- Good oral and written communications skills.
- Demonstrated project management skills.
- Demonstrated critical thinking, contingency planning and negotiating skills.
- Understanding of regulatory and business needs with ability to engage cross functional team members.
- Must be at least 18 years of age
Benefits
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Food Technologist for Regulatory team at IRCA Group managing compliance of raw materials and labels. Ensuring regulatory adherence across EU and APAC markets with a focus on food safety.
Compliance Analyst contributing to Pacific Life's mission in Consumer Affairs, reviewing and resolving complaints. Collaborating with management and internal departments for effective complaint handling.
Trade Compliance Analyst ensuring compliance with USMCA regulations through product origin analyses and audits. Supporting trade agreement monitoring and advising internal stakeholders in compliance matters.
Trade Compliance Analyst managing customs and compliance data for Canadian operations. Ensuring adherence to trade regulations and supporting internal audits and CBSA requests from the Toro Company.
Compliance Manager overseeing safety and environmental quality in multiple healthcare facilities. Leading regulatory compliance and safety procedures with continuous readiness for accreditation.
Senior Manager overseeing regulatory asset management and project delivery in a global biopharma company. Leading cross - functional collaboration to ensure oversight and compliance with regulatory strategies.
Ethics & Compliance Summer Intern supporting daily tasks and departmental projects in compliance and auditing. Gaining hands - on experience in risk management and cross - functional collaboration.
Senior Compliance Engineer supporting EMC testing and compliance for new product development at Stryker Medical. Collaborating with teams to ensure regulatory compliance throughout product lifecycle.
Compliance Manager executing risk - based compliance reviews and surveillance within investment management firm. Supporting compliance activities across Americas with emphasis on testing and reporting.