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Regulatory Affairs Manager in Yorba Linda, California at Nobel Biocare

Date Posted: 2/19/2019

Job Snapshot

Job Description

Job ID: NOB002865

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 Regulatory Affairs (RA) Manager, with very minimal supervision, develops and provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optional timelines for new/modified product launches.
  • The RA Manager will be responsible to conduct regulatory assessments regarding requirements and timelines for product approval in close collaboration with the product development group and/or as assigned by RA Management.
  • The RA Manager will be responsible for RA deliverables linked to the management of projects related to US/EU product registrations and US/EU life cycle management activities.
  • The RA Manager will be responsible for developing and executing regulatory strategies as assigned for projects intended for US/EU release.
  • The RA Manager may also be asked to support RA related parts in audits and routine RA maintenance activities.
  • The RA Manager is expected to be aware of the current US/EU legislative environment and maintain an over view of the regulatory requirements.
  • The RA Manager will be involved in the assessment, approval and release of communication material (IFU, leaflets, brochures) and development/improvement of RA related processes. 
  • The RA Manager may be required to train and assist other departments to ensure continued regulatory compliance.
  • Consulting of RA and product development in cross functional teams.
  • Accountable for 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/EU.
  • Training internally on relevant procedures and requirements.
  • Highly organized and able to work under strict time lines.
  • Excellent writing and communication skills.

Job Requirements



Qualifications

REQUIREMENTS:
  • A minimum of a Bachelor’s degree from accredited college or university is required. A degree focused in science, biomedical engineering, is preferred.
  • Experience in the preparation,submission and clearance of US Regulatory files (510(k)s, PMAs) is required.
  • Minimum 7+ years experience in regulatory affairs within the Medical Device Industry.

PREFERRED SKILLS/EXPERIENCE:
  • Experience in preparation for notified body audits and FDA inspections.
  • Experience in managing cross functional projects and team.
  • Experience with US and EU medical Device regulations.
  • Experience with software development requirements (IEC 62304 ), usability (IEC 62366) as well as electro-mechanical product standards such as IEC 60601 a plus.
  • Experience with quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820.
  • Knowledge of medical device legislation US and EU corresponding guidelines.
  • Very experienced in driving US registration projects.
  • Good knowledge of product development processes in MD industry.
  • Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820.  
  • Experience with Medical Software is preferred.
  • Fluent in English further languages are an advantage.
  • Highly organized and able to work under strict time lines.
  • Strong interpersonal skills and proactive working attitude in a international matrix organization.
  • Excellent writing and communication skills.
  • High intercultural competency.
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.


Danaher Corporation Overview

Danaher's Dental Platform is a $3B global business focused on all aspects of dental care.  With the intention to spin-off the Dental Platform to become its own public company in the second half of 2019, “Dental Co” will become one of the largest and most innovative dental companies in the world.  We are changing the face of dentistry with our differentiated portfolio of products designed to serve every dental professional’s need. It is our mission to make our dentist's work simpler and better connected so more patients are cared for in a shorter time. Our dental brands include traditional consumables and equipment (KaVo Kerr) and specialty products (Ormco and Nobel Biocare).