Regulatory Affairs Lead
2 days ago
Salary: $120,000 - $150,000 per year
About UsDentsply 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, we develop, manufacture, and market 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.
We provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dentistry. Our global headquarters is located in Charlotte, North Carolina, USA, and our company's shares are listed in the United States on NASDAQ under the symbol XRAY.
What We OfferWe 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 part of a team that shapes an industry, then we're looking for the best to join us.
- 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.
The primary job responsibility for this position is overseeing the day-to-day functions of Dentsply Sirona's Implant and Prosthetic Solutions regulatory initiatives. This role develops global regulatory strategies for new products and assesses design changes to existing products. Prepares and manages submissions in the US, including but not limited to 510(k)s, QSUBs, and 513(g)s.
This individual will also be responsible for mentoring and providing guidance to their direct reports as well as cross-functional product development teams on US and EU regulations to support regulatory submissions and product commercialization.
Key Responsibilities- Develops and implements regulatory strategies to obtain and maintain regulatory clearances and/or approvals for medical devices globally.
- Leads and manages regulatory submissions, including 510(k) submissions, and technical files.
- Manages communications with FDA and EU notified bodies on behalf of the company for FDA QSUBs, FDA 510(k) submissions, and EU technical file submissions.
- 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.
- Reviews and approves product labeling and claims for the US and EU markets.
- Stays current with regulatory requirements and updates affected policies and procedures.
- Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
- Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.
- Complies with company and departmental policies and administrative requirements.
- Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
- Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.
- 5(+) years of experience in regulatory affairs, preferably in the medical device industry. Experience with leading U.S. and E.U. regulatory submissions and managing regulatory projects.
- In-depth knowledge of FDA and international regulations (e.g., EN ISO 13485, EU MDR).
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