Envista Holdings Corporation Senior Regulatory Affairs Specialist in Topeka, Kansas
The Kerr Dental portfolio of brands and product solutions spans restoratives, endodontics, and rotary instruments, with a common purpose of enabling healthy, beautiful smiles while providing an exceptional customer experience globally. Kerr’s 130+ year history of innovation began in 1891 in Detroit, Michigan and has since expanded on a global scale to ensure dental professionals receive the consumable products they trust most. Kerr’s market-leading brands include OptiBond, SonicFill, Harmonize, MaxCem Elite, and many more. Learn more at www.kerrdental.com
We are looking for a highly motivated Senior Regulatory Affairs Specialist that will be responsible for executing submissions, developing regulatory strategy, and ensuring compliance to world-wide regulations. As part of the team, this individual is responsible for obtaining regulatory clearances based on company objectives, acting as a liaison between the organization and state, local, federal, and international agencies, attending product development meetings, project meetings; as well as collaborating with cross-functional departments to ensure requirements are met and integrated throughout the design control and post-product launch activities.
Essential Duties and Responsibilities:
Write, coordinate, compile, and submit Regulatory submissions (new product registrations, amendments, notifications) to EPA, along with other Regulatory Agencies, including FDA.
Write, coordinate, compile, and submit Regulatory submissions (new product registrations, amendments, notifications) to Health Canada DIN (Drug Identification Number), Medical Device License, Establishment License application packages as well as subsequent renewals.
Liaison with regulatory agencies regarding any regulatory matters and submission related correspondence.
Strategize regulation submissions according to Business Needs.
Provides regulatory guidance to cross-functional project teams.
Plans and coordinate State EPA Submissions to align with Product Launch Timelines.
Completes Regulatory Assessments and Evaluates proposed product modifications to ensure compliance with FDA, EPA, Health Canada and any other applicable regulations.
Reviews and Approves Product Labeling as well as MAPSS (Marketing, Advertising, Promotional, Scientific and Sales Materials) materials.
Assist in 510(k) Assessment for Class I non-exempt and Class II device products.
Performs NDC (National Drug Code) Listing and Drug Establishment Registration and subsequent renewals for OTC Drug products.
Prepares responses to Regulatory authority questions, as well as other Regulatory correspondence.
Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company.
Represents and provides regulatory guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projects.
Support UDI and GUDID database operations.
Supports Internal and External Audits including FDA and EPA inspections.
Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body.
Review and assess product modifications, manufacturing and labeling changes for global regulatory impact and compliance.
Reviews and Approves NCRs as needed.
May mentor junior Regulatory Team members and delegate tasks within a well-defined scope.
- Bachelor's Degree (BA/BS) from four-year college/university and/or 5+ years regulatory experience
Strong analytical thinking, problem solving, and investigate skills.
Organizational skills; ability for detail and precision.
Team player with ability to work independently.
Excellent written and oral communication skills.
Strong interpersonal and presentation skills with the ability to influence others in a positive and effective manner.
Project management skills.
Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.
Strong computer skills in Word, Excel and PowerPoint.
Ability to work under minimal supervision.
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.