Sr. Regulatory Affairs Specialist

Envista Dentistry•Brea, CA

8d•Onsite

About The Position

The Sr. Regulatory Affairs Specialist will be primarily responsible for supporting the development of RA strategies for new product development for a range of dental restorative, endodontic, and rotary products. Responsibilities include preparing/submitting regulatory filings for US 510(k)s, Canada, and EU MDR. Medical devices Essential Duties and Responsibilities: Working primarily independently, applies forward thinking when drafting and proposing regulatory strategies for sustaining and new products including but not limited to creating action plans and supporting the completion of milestones. Reviews and interprets applicable standards, regulations, and directives for dental devices to ensure compliance with applicable regulations. Represents the RA function on core teams with cross-functional teams and applies expertise when providing RA guidance to support project deadlines. Assembles the deliverables of domestic and/or international product registration submissions including 510ks, Conformité Européenne (CE) Technical Files, and/or dossiers for international registrations. Executes deliverables related to the US and Canada submission. Ensure products comply with applicable FDA regulations (21 CFR) , Health Canada Medical Device Regulations , and international standards. Prepare, review, and submit U.S. FDA submissions, including: 510(k)s (e-star), Pre-submission (Q-Sub) packages, Device listing, establishment registration, post-market regulatory documentation Prepare and lead Health Canada submissions, such as: Medical Device License (MDL) applications; Amendments, renewals, and supporting technical documentation via the REP process; Coordinate responses to regulatory agency requests and deficiency letters. Lead and maintain UDI strategy, implementation, and compliance across product lines. Support global UDI requirements through collaboration with internal teams and external partners Manage GUDID submissions, updates, and ongoing database accuracy. Support internal audits, inspections, and regulatory assessments. Authors/updates department Standard Operating Procedures (SOP) to address and demonstrate compliance to standards, regulations, etc. Executes deliverables related to preparing international Dossier files. Executes Engineering Change Request (ECO) and Engineering Change Reports (ECR) and performing regulatory assessments. Reviews labeling and promotional material. Supports the execution of regulatory deliverables for clinical studies. Mentors and guides junior RA personnel. Supports their development by providing leadership with skills gaps in training and experience. Maintains expertise of Quality System Regulations and Design Controls and their relevance to medical devices. Prepares various status reports for Key Performance Indicators (KPI) reporting to Regulatory Affairs Management. Champions and participates in continuous improvement activities under the Envista Business System (EBS) and supports the implementation of actions. Implements EBS tools into RA activities and standard work. Responsible for execution of EBS practices into RA activities and standard work. Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Constantly sits. Frequently uses hands and fingers. Occasionally walks and stands. Rarely bends and stoops. Occasionally reaches up/down with arms. Occasionally lifts and/or moves up to 5 lbs.

Requirements

Bachelor’s degree in a related field or 7+ years of relevant work experience in medical, pharmaceutical, healthcare or a regulated industry in lieu of education.
5+ years of Regulatory Affairs work experience or equivalent in the medical, pharmaceutical, healthcare or a regulated industry
Expertise in domestic and/or international medical device regulations, including but not limited to 510ks, European Union (EU) Medical Devices Regulation (MDR), and/or global registration requirements.
Must reside within a commutable distance to Brea, CA. This is a fulltime onsite role and not hybrid or remote.
Strong technical writing skills and the ability to translate to all levels of employees required.
Exceptional analytical skills and ability to solve a range of complex problems required.
Strong professional presentation skills and ability to negotiate effectively required.
Detail-oriented and the ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists required.
Strong project coordination and prioritization skills are required.
Ability to build and maintain good rapport and handle situations with confidence, tact, and resourcefulness required.
Ability to adapt to changing priorities in a fast-paced environment required.
Effective verbal and written communication skills in English required.
Ability to read and interpret documents in English required.
Intermediate with Microsoft Office Suite including Word, Excel, and Outlook.
Proven success in building and maintaining good rapport and handling situations with confidence, tact, and resourcefulness required.
Assists management with coordination of RA activities as required.

Responsibilities

supporting the development of RA strategies for new product development for a range of dental restorative, endodontic, and rotary products
preparing/submitting regulatory filings for US 510(k)s, Canada, and EU MDR
drafting and proposing regulatory strategies for sustaining and new products including but not limited to creating action plans and supporting the completion of milestones
reviewing and interpreting applicable standards, regulations, and directives for dental devices to ensure compliance with applicable regulations
representing the RA function on core teams with cross-functional teams and applies expertise when providing RA guidance to support project deadlines
assembling the deliverables of domestic and/or international product registration submissions including 510ks, Conformité Européenne (CE) Technical Files, and/or dossiers for international registrations
executing deliverables related to the US and Canada submission
ensuring products comply with applicable FDA regulations (21 CFR) , Health Canada Medical Device Regulations , and international standards
preparing, reviewing, and submitting U.S. FDA submissions, including: 510(k)s (e-star), Pre-submission (Q-Sub) packages, Device listing, establishment registration, post-market regulatory documentation
preparing and lead Health Canada submissions, such as: Medical Device License (MDL) applications; Amendments, renewals, and supporting technical documentation via the REP process; Coordinate responses to regulatory agency requests and deficiency letters
leading and maintaining UDI strategy, implementation, and compliance across product lines
supporting global UDI requirements through collaboration with internal teams and external partners
managing GUDID submissions, updates, and ongoing database accuracy
supporting internal audits, inspections, and regulatory assessments
authoring/updating department Standard Operating Procedures (SOP) to address and demonstrate compliance to standards, regulations, etc
executing deliverables related to preparing international Dossier files
executing Engineering Change Request (ECO) and Engineering Change Reports (ECR) and performing regulatory assessments
reviewing labeling and promotional material
supporting the execution of regulatory deliverables for clinical studies
mentoring and guiding junior RA personnel. Supports their development by providing leadership with skills gaps in training and experience
maintaining expertise of Quality System Regulations and Design Controls and their relevance to medical devices
preparing various status reports for Key Performance Indicators (KPI) reporting to Regulatory Affairs Management
championing and participating in continuous improvement activities under the Envista Business System (EBS) and supports the implementation of actions
implementing EBS tools into RA activities and standard work
responsible for execution of EBS practices into RA activities and standard work