Regulatory Affairs Specialist III
Thermo Fisher Scientific

Asheville, North Carolina

This job has expired.


Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Discover Impactful Work:

The Regulatory Specialist is responsible for product compliance, design consultation, testing, and submission activities for ensuring global regulatory compliance. This position is responsible to carry out policies, procedures, practices, and strategies in collaboration closely with international Regulatory, R&D, Marketing, Quality, Operations, Service, and other functions. This role supports implementation of requirements for laboratory and medical devices from product inception, and throughout the product lifecycle.

A day in the Life:

  • Participates on New and Existing Product Development teams, providing regulatory requirements, strategies, timelines, and direction for global markets.
  • Completes product change assessments and define regulatory impact of product changes in markets.
  • Recommends changes for design, labeling, manufacturing, and marketing for regulatory compliance.
  • Reviews, approves, and creates technical documentation.
  • Engages with regulatory agencies and authorities to resolve questions or issues.
  • Collaborates with NRTL and other test labs for product testing, certifications, and site inspections.
  • Monitors and improves processes and tracking / control systems.
  • Creates and improves regulatory procedures.
  • Performs all job duties in a safe manner and obey all safety policies and procedures.
Requirements
  • STEM-related Bachelor's degree with 3+ years of experience in product compliance, quality, or regulatory affairs, OR STEM-related advanced degree with 2+ years of experience in product compliance, quality, or regulatory affairs.
Suggested Experience
  • Excellent knowledge of international regulations and standards.
  • Experience reviewing design specifications and other technical documents.
  • Experience with post-market surveillance activities, CAPAs, and investigations.
  • Suggested prior experience in manufacturing environments for Medical Device or Pharmaceutical products.
  • Working knowledge of product standards such as EN IEC 61010-1 and EN IEC 61326-1.
  • Risk based thinking and functional knowledge in risk assessment activities per ISO 12100 or ISO 14971.
  • Procedure writing, technical writing, and/or instructing experience.
Knowledge, Skills, Abilities
  • Works well in dynamic and cross functional team environments.
  • Solid understanding of manufacturing processes and product change controls.
  • Understanding and application of global compliance requirements - Safety, EMC, Wireless, Environmental, etc.
  • Proven systematic thinking and analytical reasoning abilities.
  • Must demonstrate collaboration skills in team setting.
  • Excellent communication skills, both oral and written.
Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.


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