Regulatory Affairs Specialist
Sybron Dental Specialties - Orange, CA

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SYB000171

OPCO Description

Sybron Dental Specialties (SDS) is a leading dental consumables company with revenue approaching $1B. SDS is comprised of three platforms Dental Consumables which has Kerr, Pentron and Axis, Dental Medical Solutions and Devices which has Total Care, Metrex and Orascoptic and Specialty Products which has Ormco, SybronEndo and Sybron Implant Solutions and Allesee Orthodontic Appliances,— all are leading brands that addresses the consumable needs of the dental profession. All Sybron companies have strong brand names, proprietary technologies and major market positions. Building on the foundation provided by Danaher Business System and the company’s core values, our associates are pursuing a focused strategy aimed at creating a Premier Global Enterprise.

Description

Summary:
This position is responsible for regulatory submissions in support of product clearances and approvals.

Essential Duties and Responsibilities:
include the following. Other duties may be assigned.

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Responsible for the preparation and compilation of FDA 510ks applications and US EPA pesticide registration submissions, including follow-up inquiries

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Support domestic and international field corrective actions, including preparation and/or review of meeting minutes, initial recall notifications, monthly status reports and requests for recall closure

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Update and maintain Recall Log for all SDS business units

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Responsible for FDA device/drug establishment registrations and device/drug listings

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Ability to represent the RA department in team meetings, effectively interacting with manufacturing, R&D, Sales/Marketing and QA to meet project deadlines

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Review and assess regulatory requirements for potential new products, design changes and manufacturing process changes

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Prepare and submit FOIA requests to EPA/FDA

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Assist in the regulatory review of product labels, literature and websites

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Prepare monthly status reports for the VP of Regulatory Affairs

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Perform special projects as needed

Qualifications

Qualifications:
Bachelor's Degree

5 years experience working at an FDA-regulated company.

Strong working knowledge of medical device regulations, including 510k submissions.

Knowledge of EPA pesticide and Canadian drug regulations is desirable.

Excellent written and oral communication skills.

Strong analytical and organizational skills; ability for detail and precision.

Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.

Ability to solve practical problems, and deal with a variety of concrete variables in situations where only limited standardization exists.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer literate in Word, Excel, and PowerPoint.

Must have the ability to work in a team-oriented environment, and is able to meet tight deadlines.

Benefits:
Sybron Dental Specialties recognizes the innovation and energy of its employees with competitive compensation and a full range of benefits, including medical/dental/vision, retirement plan, and much more.

Please no faxes or phone calls. Only considered candidates will be contacted.

Thank you for your interest in Sybron Dental Specialties!

We are proud to be an EEO/AA employer M/F/D/V.

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Danaher Overview

Danaher Corporation designs, manufactures, and markets professional, medical, industrial, and consumer products, which all generate approximately $13 Billion in revenue. Danaher’s business activities encompass four reporting segments and are comprised of six strategic platforms: Medical Technologies, Professional Instrumentation (Environmental, Electronic Test), Industrial Technologies (Motion, Product ID, and Focused Niche Businesses) and Tools & Components (Mechanic’s Hand Tools). Danaher operates globally with about 50% of its revenues derived from outside the United States. The Company has significant operating businesses headquartered in Europe and has greatly expanded its operating presence in Asia over the past several years. Danaher is a well-capitalized business, which has historically used available cash flow to fund acquisition activity. Culturally, the company operates in a highly de-centralized model with an extremely lean corporate structure. Danaher has a proven system for achieving performance: the Danaher Business System (DBS). It drives every aspect of the group’s culture and performance. DBS is a system of continuous improvement and is used to guide and measure everyday activities, which has enabled it to double in size about every 5 years with impressive financial performance.

Organization

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Sybron Dental Specialties

Job Function

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Quality

Primary Location

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North America-United States-CA-Orange

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Schedule

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Full-time

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About this company
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Sybron Dental Specialties, Inc. (SDS) is a manufacturer of value-added products for the dental profession, including the marketing of...