Regulatory Affairs Specialist: 12-month Contract
Natus Medical Incorporated is a company that has been delivering industry-leading neuro solutions for over 80 years. They are currently seeking a Regulatory Affairs Specialist for a 12-month contract position to manage international regulatory submissions and ensure ongoing compliance across global markets.
Responsibilities
- Manage international regulatory submissions and registration processes, including regions such as LATAM (e.g., Brazil ANVISA), APAC (e.g., Japan PMDA, China NMPA), and EMEA markets
- Interpret and apply regulatory requirements, with a focus on EU MDR 2017/745 and global standards
- Develop, update, and maintain internal quality procedures and product-specific documentation
- Collaborate with global Regulatory Affairs teams to ensure consistency and compliance
- Prepare and maintain Technical Files and Design Dossiers for CE Marking and regulatory submissions
- Monitor project progress and report on MDR compliance milestones
- Support audits from Notified Bodies, Competent Authorities, and other regulatory agencies
Skills
- Bachelor's degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related field
- Minimum of 1 year of relevant experience in medical device regulatory affairs
- Strong knowledge of medical device regulations: ISO 13485, MDD, MDR, and other international frameworks
- Technical writing skills and attention to detail
- Ability to work methodically and drive continuous improvement
- English language fluency required
- Regulatory Affairs Certification (RAC) is a plus
Benefits
- Company bonus or commission plan
Company Overview