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Sr. Regulatory Affairs Specialist in Yorba Linda, California at Nobel Biocare

Date Posted: 1/8/2019

Job Snapshot

Job Description

Job ID: NOB002778

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


Description

The Sr. Regulatory Affairs Specialist, with minimal supervision, provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Responsible for coordinating efforts associated  with US Regulatory submission (e.g., 510k Submissions, FDA correspondences) as assigned for by RA Management.
  • Responsible for executing Regulatory strategies as assigned by RA Management for projects in the US.
  • May also be asked to participate in RA related parts in site audits and routine RA maintenance activities.
  • Is expected to be aware of  the current the US legislative environment and maintain an overview of the regulatory requirements.
  • May be involved in the writing or updating of SOPs and work instructions with minimal supervision.
  • May be involved in preparation of assessment, approval of communication material (IFU, leaflets, brochures) and development/improvement of RA related processes.
  • Execution of Regulatory strategy for assigned development projects.
  • Participate in cross functional teams.
  • Creation, review, and/or approval of documents of the design control process .
  • Support regulatory compliance.
  • Assessment, approval and regulatory implementation of change requests.
  • Review and approval of product related labeling and marketing material.
  • Support SAP based reporting systems.
  • Monitoring legislative environment in US.

Job Requirements



Qualifications

EDUCATION/EXPERIENCE:
  • Bachelor’s degree from accredited college or university is required.
    • A degree focused in science, biomedical engineering, is preferred.
  • 3+ years of experience in Regulatory Affairs within the Medical Device Industry. Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) is required.
    • Experience in preparation for notified body audits and FDA inspections.
    • Experience in being an active participant in cross functional projects and team is required.
    • Experience with US and Canadian medical Device regulations is required. 
QUALIFIED CANDIDATES WILL POSSESS:
  • Knowledge of medical device legislation US and Canadian corresponding guidelines.
  • Knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820. 
  • Knowledge of product development processes in Medical Device industry.
  • Highly organized and able to work under strict time lines.
  • Strong interpersonal skills and proactive working attitude in an international matrix organization.
  • Excellent writing and communication skills.
  • High intercultural competency.
  • Highly organized and able to work under strict time lines.
  • Excellent writing and communication skills.
  • Fluent in English (fluency in other languages are a plus).
PREFERRED QUALIFICATIONS:
  • Experience with Medical Device Software is preferred.
  • Experience with software development requirements (IEC 62304), usability (IEC 62366) as well as electro-mechanical product standards such as IEC 60601, a plus.
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 industrial solutions. Our globally diverse team of 59,000 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 #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 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.