Regulatory Affairs Manager- Remote

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.

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 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).

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.
• 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