Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
Regulatory Affairs Specialist Job Description Template
Our company is looking for a Regulatory Affairs Specialist to join our team.
Responsibilities:
- Ensure current regulations and standards are available;
- Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist;
- Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations;
- Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate;
- Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained;
- Assist in enforcing and supporting regional procedures to ensure HRM data entry and usage compliance;
- Manage responses to customer enquiries regarding product safety and regulatory compliance;
- Support, and at times lead, efforts surrounding HRM regional specific projects and maintain appropriate metrics;
- Plan schedules for regulatory deliverables on a project and monitors project through completion;
- Work with cross functional teams – with senior support – to deliver supporting documentation (IFU, DHF, CER etc.);
- Partner with other functions to define and obtain data to assist with regulatory submissions;
- Review and approve labelling and instruction for use;
- Support the generation of technical documentation and the writing and compilation of technical files;
- Assist in the implementation of HRM data quality strategies in the region and support users in the execution of the strategy at the country level;
- Represent Regulatory Affairs on cross-functional project teams.
Requirements:
- Ability to address a wide range of cultures, disciplines and levels within the organization;
- Practical experience with the preparation and submissions for Class II and III medical devices (EU and USA);
- Expertise with SAP EHS module;
- Substantial experience of US, EU and International Regulations required;
- Knowledge of additive manufacturing technology and associated regulations (Software), advantageous;
- Willingness and ability to work effectively in a large multi-national matrix organization;
- Bachelor’s degree in engineering, chemistry, environmental and health science, regulatory affairs, Toxicology or related technical discipline;
- BS with minimum 6 years of experience or equivalent;
- Minimum of 2 years of experience in Product Stewardship/Regulatory Affairs;
- Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.