Regulatory Affairs Manager

Responsibilities

• Overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team
• Developing regulatory strategies for existing, new, and modified medical devices and other (regulated) products
• Managing and submitting 510ks for the products and managing communications with FDA including pre-submissions
• Mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements
• Working closely with business partners for registrations in their respective countries to ensure compliance globally and acting as an internal champion for initiatives aimed at improving business systems and compliance
• Developing and implementing regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally
• Leading and managing regulatory submissions, including 510(k) submissions, and technical files for CE marking
• Managing 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
• Providing regulatory guidance and support to cross-functional teams throughout the product lifecycle
• Reviewing and interpreting regulatory requirements and guidance documents to ensure compliance
• Capturing and coordinating 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
• 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
• Solves conflicts and fosters a positive working environment

Requirements

• 5(+) years of experience in regulatory affairs, preferably in the medical device industry
• Experience with leading regulatory submissions and managing regulatory projects
• In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)

Computer / Software Skills

• Proficiency with Microsoft Office Suite
• Proficiency with Regulatory software

Leadership, Project Management, and Organizational Skills

• Strong leadership, project management, and organizational skills including attention to detail

Written and Verbal Communication Skills

• Strong written and verbal communication skills

Prior Technical Writing Experience and Proven Track Record with FDA and EU Regulatory Submissions

• Prior technical writing experience and proven track record with FDA and EU regulatory submissions

Interpersonal Skills

• Prioritizes and works effectively in a team environment and independently

Knowledge of Regulatory Affairs Principles and Practices

• 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

• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported

Willingness to Learn and Adapt to New Processes and Technologies

• Willingness to learn and adapt to new processes and technologies

Leadership Experience Within Medical Device Organizations

• Leadership experience within medical device organizations

Strong Results Orientation and Analytical 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

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