Sr. Regulatory Affairs Specialist
- Charlotte, NC
- Permanent
- Full-time
- Leads regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions, and technical files for CE marking
- Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle
- 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
- Stays current with regulatory requirements and updates affecting medical devices
- Fosters professional interactions with internal and external 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
- Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline
- 5(+) years of experience in regulatory affairs, preferably in the medical device industry
- Experience with leading regulatory submissions and documentation, including 510(k) submissions and CE marking
- In-depth knowledge of FDA regulations and international standards (e.g., ISO 13485)
- Proficiency with Microsoft Office Suite
- Proficiency with Regulatory software
- Strong leadership, attention to detail and organizational skills
- Excellent communication and interpersonal skills
- Ability to work effectively in a team environment
- Knowledge of regulatory affairs principles and practices
- Willingness to learn and adapt to new processes and technologies
- Leadership experience within med device organizations
- Strong organizational skills, including attention to detail
- Strong written and verbal communication
- Exceptional interpersonal skills