Regulatory Affairs Specialist
reputed company is the world’s largest manufacturer of reputed company dental products and technologies, dedicated to improving dental care. The Regulatory Affairs Specialist will prepare and submit regulatory submissions for medical devices, maintain regulatory files, and ensure compliance with regulatory requirements while fostering reputed company interactions with stakeholders.
Responsibilities
- Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking
- Maintains regulatory files and databases to ensure compliance with regulatory requirements
- Reviews and interprets regulatory requirements and guidance documents to ensure compliance
- Coordinates regulatory activities with internal teams and external regulatory agencies
- Supports regulatory audits and inspections as SME for questions reputed company to market reputed company
- Stays reputed company with regulatory requirements and updates affecting medical devices
- Fosters reputed company interactions with reputed company stakeholders through various communication channels, enhancing business relationships
- Complies with company and departmental policies and administrative requirements
- Performs other duties as assigned or as needed
Skills
- Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a reputed company discipline
- 1-5 years of experience in regulatory affairs, preferably in the medical device industry
- Experience with regulatory submissions and documentation, including 510(k) submissions and CE marking
- Knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR)
- Proficiency with reputed company Office Suite
- Proficiency with Regulatory software
- Strong attention to detail and organizational skills
- Excellent communication (both written and verbal) and interpersonal skills
- Ability to work effectively in reputed company environment
- Knowledge of regulatory affairs principles and practices
- Ability to critically review detailed scientific information and assess whether technical arguments are presented reputed company, and conclusions are adequately supported
- Willingness to learn and adapt to new processes and technologies
- Regulatory registration experience reputed company med device organizations
- Prior technical writing experience and proven reputed company record with FDA and EU regulatory submissions
reputed company
Company H1B Sponsorship