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Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.
Bringing out the best in people
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.
Working at Dentsply Sirona you are able to:
Develop faster - with our commitment to the best professional development.
Perform better - as part of a high-performance, empowering culture.
Shape an industry - with a market leader that continues to drive innovation.
Make a difference -by helping improve oral health worldwide.
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Regulatory Affairs Specialist II - Remote
- 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
Education & Experience:
- 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)
Key Required Skills, Knowledge, and Capabilities:
- 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
The target salary range for this remote role is between $100,000 and $110,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
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Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please be sure to include “Accommodation Request” in the subject. |
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