Regulatory Affairs Manager

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Location: Milford, DE, US, 19963 Sarasota, FL, US, 34243 Johnson City, TN, US, 37601 Waltham, MA, US, 2451 Charlotte, NC, US, 28277 York, PA, US, 17404

Company: Dentsply Sirona, Inc

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.

This position can be a hyrbid working arrangement, for someone that is near any of the following locations:
Milford DE, Sarasota FL, Charlotte NC, Johnson City, TN, Waltham, MA, or York, PA

The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.

This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.

• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
• Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
• Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files 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 labelling 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.
• Performs other duties as assigned or as needed.

• Bachelor's degree in a relevant…