Senior Regulatory Affairs Specialist

Description:

Dentsply Sirona, the world’s largest manufacturer of professional dental products and technologies with over 130 years of innovation, is seeking a Sr. Regulatory Affairs Specialist. This role is critical in leading regulatory submissions, ensuring compliance with global medical device regulations, and maintaining approvals for a wide range of dental and oral health products.

As a Senior Regulatory Affairs Specialist, you will provide expert guidance across the product lifecycle, collaborate with cross-functional teams, and ensure adherence to FDA regulations, CE marking requirements, and international standards. This position offers the opportunity to work in a high-performance, innovative environment that advances global oral health.

Key Responsibilities:

• Lead regulatory submissions to obtain and maintain medical device approvals, including 510(k) submissions and technical files for CE marking.

• Provide regulatory guidance to internal teams throughout product development and commercialization.

• Review and interpret regulatory requirements to ensure compliance with applicable laws and standards.

• Coordinate regulatory activities with internal departments and external regulatory agencies.

• Support audits, inspections, and responses to regulatory bodies.

• Stay updated on evolving regulatory requirements impacting medical devices.

• Foster strong professional relationships with internal stakeholders and external agencies.

• Comply with company policies and administrative requirements.

Qualifications & Skills:

Required:

• Bachelor’s degree in life sciences, regulatory affairs, or a related discipline.

• Minimum 5 years of regulatory affairs experience in the medical device sector.

• Proven experience in regulatory submissions (510(k) and CE marking).

• In-depth knowledge of FDA regulations and international standards (ISO 13485).

• Strong organizational skills with exceptional attention to detail.

• Excellent communication and interpersonal abilities.

• Proficiency with Microsoft Office and regulatory software tools.

Preferred:

• Leadership experience within medical device organizations.

• Ability to work effectively in a team-oriented, fast-paced environment.

• Willingness to adapt to new processes and technologies.

Why Join Dentsply Sirona?

• Work with a market leader shaping the future of dental care.

• Opportunities for professional development and growth.

• Contribute to global oral health advancements.

• Be part of a high-performance, innovation-driven culture.