Sr. Regulatory Affairs Specialist

Requistion ID : 84598

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century 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 dental care. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.

Scope/Summary
Leads global regulatory affairs activities for medical devices, ensuring timely product approvals and ongoing compliance with FDA, CE Marking, and other applicable regulatory requirements. Provides strategic regulatory guidance across the product lifecycle, partnering with cross-functional teams to support market access, risk management, and business objectives while maintaining regulatory excellence.

Key Responsibilities

- 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

Key Leadership Behaviors

- Actively articulates and promotes Dentsply Sirona’s vision and direction

- Advocates on behalf of the customer

- Values driven with an insistence on excellence

- Promotes high performance, innovation, and continual improvement

- Consistently meets Company standards, ethics, and compliance requirements.

- Strong results orientation and analytical skills

- Excellent mathematical, statistical, & IT skills as it pertains to data extraction, manipulation, and modelling.

- Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.

Typical Background

Education:

- Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline

Years and Type of Experience:

- 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)

Required Computer / Software Skills:

- Proficiency with Microsoft Office Suite

- Proficiency with Regulatory software

Key Required Skills, Knowledge, and Capabilities:

- 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

Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

Eligibility: All successful applicants must be eligible to work in the country the position is based.

Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected] .

Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.

Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com .