Regulatory Affairs Manager (USA Home Office, --, US, NA)

This position can be a remote working arrangement. Candidates must be located in the US, ideally in the eastern time zone.

Job Summary:

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.

Key Responsibilities:

• 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.

Education:

• 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.

Years and Type of Experience:

• 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).
• Experience with software as a medical device, AI and/or medical devices containing software is a plus

Required Computer / Software Skills:

• Proficiency with Microsoft Office Suite
• Proficiency with Regulatory software

Key Required Skills, Knowledge, and Capabilities:

• 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.
• 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.
• Willingness to learn and adapt to new processes and technologies.
• Leadership experience within medical device organizations.

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.
• Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
• Resolves conflicts and fosters a positive working environment.