Regulatory Affairs Specialist
3 weeks ago
Innovative Health LLC is seeking a highly skilled Regulatory Affairs Engineer to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with FDA regulations and international standards for medical devices.
Key Responsibilities:- Prepare and submit 510(k) submissions to obtain FDA clearance for commercial distribution of medical devices;
- Develop and maintain regulatory documents for international regulatory bodies, including technical files and design dossiers;
- Review and approve test protocols, reports, and other documentation for regulatory submissions;
- Participate in project development teams and review plans, reports, and risk assessments associated with product and process projects;
- Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities;
- Conduct internal and external audits and prepare responses to support audit findings;
- Review and approve change orders, CAPA, and nonconformance reports;
- Assist with label and IFU development and review for compliance;
- Review promotional material to ensure compliance with applicable regulations;
- Implement and maintain unique identifier (UDI) activities for compliance;
- Assist with FMEA risk assessments;
- Maintain and disseminate current knowledge base of existing regulations, standards, and guidance documents;
- Develop and implement company policies and procedures;
- Assist in archiving regulatory documentation and maintaining related repository.
Qualifications:
- Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field);
- Experience and knowledge of FDA 21 CFR Part 820 and 510K submission requirements;
- Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP, and ISO standards preferred;
- Minimum of three years medical device experience;
- Working knowledge of QMS systems and functionality;
- Previous 510(k) submissions preferred;
- Ability to work in a fast-paced, collaborative team environment;
- Ability to handle multiple projects and coordinate cross-functional teams;
- Ability to communicate effectively with management, direct reports, and external vendors;
- Ability to write technical documents (procedures, test methods, protocols, and reports);
- Ability to recommend technical solutions;
- Ability to specify regulatory requirements for products;
- Ability to work with little supervision;
- Ability to use personal computers, including software such as: Word, PowerPoint, Excel, Project, and Minitab;
- Self-starter and highly motivated.
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