Regulatory Affairs Senior Manager in Brea, California at Ormco

Date Posted: 7/29/2019

Job Snapshot

Job Description

Job ID: ORM001646

About Us

For nearly 60 years, Ormco has partnered with the orthodontic community to manufacture innovative products and solutions to enhance the lives of our customers and their patients. Distinguished products range from legacy twin brackets (Inspire ICE™, Titanium Orthos™ and Mini Diamond™) to pioneering the self-ligating appliances with the Damon™ System (including Damon™ Q2 and Damon™ Clear 2). Ormco’s Insignia™ Advanced Smile Design™ provides an all-inclusive customized indirect bonding solution for increased clinical efficiency. From personalized service to professional education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives. For more information, visit www.ormco.com.



Description

JOB SUMMARY:
Senior Manager of Regulatory Affairs will provide leadership and management to RA staff at Ormco BU, apply expert knowledge of global medical device regulatory environment, product and regulatory requirement to develop and implement global regulatory strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Develops RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Quality goals and objectives for the Regulatory team.
  • Ensures that resources and activities are aligned with the BU objectives. Effectively communicates progress, problems, and plans.
  • Manages and develops team of Regulatory professionals. 
  • Provides appropriate mentoring, appraisals, and discipline of direct reports.
  • Responsible for product registrations, state licenses, and annual reports for Medical Device products globally, through interactions with International Sales Team, in-country business partners and ministries of health.
  • Oversees maintenance, remediation of technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
  • Oversee product recalls/field actions, including regulatory reporting per required timelines.
  • Foster and maintain strong relationships with senior RAQA Regulatory leaders across dental platform and leverage best practices and opportunities to drive cross business collaborations and initiatives.
  • Participates in audits and inspections of the company and its quality systems. 
  • Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.

Job Requirements



Qualifications

REQUIREMENTS:
  • Bachelor’s degree in a scientific discipline,
  • 5+ years in RA role within Pharmaceutical or Medical Device industry
  • 3+ years of experience managing RA associates. 
  • Ability to travel up to 10% of the time
PREFERRED SKILLS:
  • Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RA as well as across the broader organization.
  • Attracts, develops, and retains high quality employees, foster employee engagement and professional development.
  • Comprehensive knowledge and experience with global medical device regulatory requirements and product registrations.
  • Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process.
  • Direct experience with preparing and submitting materials for 510(k), MDEL and CE mark.
Danaher Corporation and all Danaher 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.


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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.