Description

In this role, you will navigate the complex regulatory landscape, ensuring product compliance from development to post-market. You will collaborate with cross-functional teams, provide guidance on regulatory requirements, and stay updated on scientific advances that shape healthcare regulations.

Requirements

• •Master’s degree in science or equivalent experience
• •In-depth knowledge of US and Canada regulations for medical devices
• •Knowledge of medical device regulations in Central America, South America (Brazil)
• •Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
• •Certifications in regulatory affairs like RAC
• •Fluency in English and any other language
• •Minimum of 3 years experience in Regulatory Affairs for medical devices
• •Experience in 510k submission
• •Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
• •Experience in working with cross-functional teams
• •Ability to integrate and demonstrate core values, integrity and accountability
• •Ability to lead, manage, collaborate and communicate within the organization

Tasks

• •Research regulatory requirements for submissions and compliance
• •Monitor the regulatory environment and provide innovative advice
• •Supervise data input activities and analyze impact reports
• •Identify needs for new regulatory procedures and develop SOPs
• •Assess market access requirements and potential obstacles
• •Evaluate preclinical, clinical, and manufacturing documents
• •Provide regulatory input on global requirements to product teams
• •Advise stakeholders on regulatory requirements for quality data
• •Collaborate with cross-functional teams on regulatory interactions
• •Communicate with regulatory authorities during submissions
• •Submit relevant reports to regulatory authorities during research
• •Notify authorities about product safety issues for compliance
• •Support inspections and audits with regulatory input
• •Submit changes and updates to regulatory authorities
• •Ensure post-market regulatory requirements are met
• •Improve quality of policies and services provided
• •Maintain knowledge of evolving regulatory information systems
• •Assist in developing and monitoring departmental budgets
• •Identify vital resources for project teams
• •Track scientific advances impacting product development
• •Participate in education and studies to meet regulatory needs
• •Engage in stakeholder groups for science-based decision-making

Benefits