Senior Regulatory Affairs Specialist

Dentsply Sirona, Inc

2d•Hybrid

About The Position

The Senior Regulatory Specialist is a contributing member of cross-functional teams in support of regulatory market access activities for US, Canada, EU, and other countries. May support NPD and Sustaining activities for the US, Canada and EU markets. Also supports additional international registrations.

Requirements

Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline
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, MDSAP, EU MDR)
Proficiency with Microsoft Office Suite
Proficiency with Regulatory software
Strong attention to detail and organizational skills
Excellent communication (both written and verbal) and interpersonal skills
Ability to work effectively in a team environment
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
Regulatory registration experience within med device organizations

Nice To Haves

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

Responsibilities

Assists in development and execution of regulatory strategies to obtain and maintain regulatory approvals for medical devices
Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking
Maintains regulatory files and databases to ensure compliance with regulatory requirements
Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle
Participates in review of labelling and claims for the US and EU markets.
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 as SME for questions related to market access
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