Regulatory Affairs Manager- Remote

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.

Job Summary:The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona 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. This role works closely with regulatory and business partners to provide support for international product registrations. This role will also ensure compliance globally and act as an internal champion for initiatives aimed at improving business systems and compliance. 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 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.

• 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).

• Proficiency with Microsoft Office Suite
• Proficiency with Regulatory software

• Strong leadership, project management, and organizational skills including attention to detail.
• Strong written and verbal communication skills.
• Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
• Excellent interpersonal skills.
• Strong results orientation and analytical skills.
• Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
• Ability to resolve conflicts and foster a positive working environment.
• Ability to work effectively in a team environment and independently.
• Knowledge of regulatory affairs principles and practices.
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• Willingness to learn and adapt to new processes and technologies
• Leadership experience within medical device organizations