1+ months

Sr. Regulatory Affairs Specialist / RA Manager

California City, CA 93505
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Location :
US - California - Carlsbad
Job Description

Job Title: Sr. Regulatory Affairs Specialist/ RA Manager
Requisition ID: 98110BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
Carlsbad, CA

How will you make an impact?

  • Thermo Fisher is seeking an experienced Regulatory Affairs professional to join the exciting area of In Vitro Diagnostic and Clinical Research products.
  • The position is located at Carlsbad, CA reporting to Sr. Manager of Regulatory Affairs and will work in the Global Regulatory Affairs department with members from Global Quality Assurance, and several Global Customer Facing Teams to evaluate and execute complaint handling, adverse event reporting, and recall strategies that are compliant to global regulatory requirements.
  • You will be responsible for managing the field action/recall process and ensuring global regulatory authorities are notified within the appropriate time restrictions.
  • In addition, you will conduct global training for regulatory compliance, maintain key MDR/recall performance metrics, participate in process improvement projects, and assist with audits.
  • You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization’s global policies and procedures to improve regulatory compliance.
  • You will continue to improve existing regulatory intelligence infrastructure that facilitates regulatory and business objectives by staying abreast of changes to relevant regulations and policies. Engage internal and cross-functional stakeholders by proactively outline and communicating risk and opportunities to regulatory strategies leading to internal policy development and alignment
  • Title is dependent upon experience.

What will you do?

  • Serve as a member of the Global Regulatory Affairs department and will have direct line reporting to Sr. RA Manager and supporting Sr. Director of Regulatory Affairs/Clinical.
  • Function as a direct link between the Global and Local RA team members to ensure local and regional regulatory strategies are developed and aligned.
  • Act as subject matter expert regarding customer complaint processing, adverse event reporting, and, field action, and recall reporting.
  • Independently lead others and conduct regulatory assessments with minimal guidance or supervision.
  • Determine global product field action and recall strategies.
  • Apply knowledge of device regulatory requirements in order to complete and submit MDR/AE reports and recall reports within regulatory timeframes.
  • Manage field action strategies and associated regulatory body notifications.
  • Maintain, develop, and modify global procedures for regulatory reporting decision models regarding recalls and MDR/AE to uphold compliance with reporting regulations.
  • Author and peer review global regulatory field action and MDR/AE reports to ensure on-time submissions to the appropriate regulatory authorities.
  • Author Health Hazard Evaluations and work with medical experts to determine potential health risks in the field.
  • Coordinate with Global Regulatory Affairs team members in APAC, EU, LATAM, and Americas regions to ensure customer complaint and nonconforming product data is properly analyzed and regional health authority reporting decisions are document adequately.
  • Ensure continued compliance with ISO 13485 and global regulatory requirements from FDA, Health Canada, Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency, and other applicable regions.
  • Generate key recalls / MDR metrics and status reports for Leadership and corporate review.
  • Participate in process improvement projects.
  • Supports process owners and global product manufacturing sites to address internal/external audit and inspection findings.
  • Responsible for SOP revisions/document creation/annual document review as assigned.
  • Review customer notifications.
  • Interface with Quality Assurance and Customer Facing Teams for product investigations and trend reporting.
  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.

How will you get here?

  • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.

Experience Requirements:

  • Must have a minimum of 3 years of IVD Regulatory Affairs experience.
  • Experience with complaint handling and recall reporting is highly desirable.
  • Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
  • Direct and positive experience in communicating with Regulatory Authorities and internal partners.
  • Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
  • Capacity to communicate regulations to technical functions within the company

Required Qualifications:

  • High energy level; positive attitude; detailed oriented; works well under stress
  • Hands-on, action-oriented, and able to implement effectively through his/her team
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
  • Able to work autonomously in a matrix-managed organization
  • Ability to provide solutions based on knowledge of regulation and industry experience
  • Willingness to travel (~10-15%)
  • Comfortable with ambiguity and change
  • Comfortable working within colleagues in different regions under tight timelines
  • Excellent knowledge-based PC computer skills essential
  • Understanding of medical terminology
  • Experience in FDA regulated environment and pertinent to ISO 13485 is preferred.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Posted: 2019-08-02 Expires: 2019-12-28

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Sr. Regulatory Affairs Specialist / RA Manager

California City, CA 93505
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