Regulatory and Compliance Engineer
Spellman High Voltage Electronics Corporation is a global manufacturing company, and the world’s leading independent manufacturer of high voltage power conversion products. We are looking for a qualified candidate for implementing and maintaining the necessary regulatory processes and documents required for Medical X-ray generators. In addition, this position will be responsible for developing and maintaining manuals and support documents/materials for Medical X-ray generators.
- Prepare, submit and maintain required documents/files for IEC60601-1 submission and subsequent updates and revisions
- Prepare and maintain required document/files according to ISO 13485, ISO 14791, 93/42/EEC, 2007/47/EC and 21 CFR 820
- Prepare, submit and maintain required documents/files for FDA submission and annual reports
- Prepare, submit and maintain required documents/files for CSA submission and annual reports
- Maintain FDA reporting and Design History File (DHF) for GXR products
- Assist in regulatory testing of GXR products
- Author and maintain operators and maintenance manuals for GXR products
- Author and maintain Service Technical Bulletins for GXR products
- Update Standard Operating Procedures (SOPs), Final Acceptance Test documents based on regulatory and government agencies requirements.
- BSc Electrical Technology/Engineering or BioMedical Engineering Technology
- Minimum 5 years of experience.
- Knowledge of the regulatory requirements for Medical Devices, CE marking and FDA
- Experience with ISO 13485, 93/42/EEC and 21 CFR 820
- Experience in submission of GXR as medical devices to regulatory agencies (Notified Body, FDA, etc.)
- Minimum two years of experience in Technical Writing
- Good communication, writing, and organizational skills
- Fluency in technical German (level C1 or higher) and English (level B1 or higher) languages
- MS Office Products – Word, EXCEL, PowerPoint, Outlook
- Experience with power electronics products, high voltage power supplies or x-ray generators is a plus
- Experience with Authoring, Desk-top publishing and Editing software: PageMaker, Adobe Acrobat, Framemaker, MS Publisher, Corel, is a plus
We at Spellman High Voltage Electronics Corporation believe that each individual is entitled to equal employment opportunities without regard to race, color, creed, gender, sexual orientation, gender identity, marital status, national origin, age, veteran status or disability. The right of equal employment opportunity extends to recruiting, hiring selection, transfer, promotion, training and all other conditions of employment.
Note to Recruiters and Placement Agencies: Spellman High Voltage Electronics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any Spellman High Voltage Electronics employee. Spellman High Voltage Electronics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Spellman High Voltage Electronics and will be processed accordingly.