200+ applicants

Company

Original Job Post

Thermo Fisher Scientific · 15 hours ago

Regulatory Affairs Specialist III

Asheville, NC

Full-time

Remote

Mid Level

4+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BioinformaticsBiotechnology

H1B Sponsorship

Actively Hiring

Insider Connection @Thermo Fisher Scientific

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Participates as a core team member on New Product Development teams, providing regulatory requirements, management of compliance verification tests, and publishing of technical documentation for global markets.

Analyzes product changes, defines regulatory impacts, and resolves gaps through interaction with testing laboratories and revision of technical documentation.

Collaborates with Quality, Engineering, and other cross-functions in support of Post Market Surveillance activities, investigations, and product improvements.

Engages with regulatory agencies and authorities to resolve questions or issues.

Collaborates with NRTLs and other testing laboratories for product testing, certifications, and site inspections.

Researches industry standard methodologies and emerging trends in regulatory compliance, and drives improvements to existing database.

Creates, monitors, and improves processes, control systems and tracking of metrics.

Performs all job duties in a safe and ethical manner, and obeys all safety policies and procedures.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Product Lifecycle ManagementRisk AssessmentISO 12100ISO 14971Manufacturing EnvironmentsMedical Devices

Required

STEM related Bachelor's degree or 4+ years of experience in product compliance, quality, regulatory affairs, or engineering.

Preferred

Involvement with product development and sustaining engineering activities, covering the entire product lifecycle.

Working within Product Lifecycle Management systems to review and approve design drawings, specifications, and other technical documents.

Participating in post-market surveillance activities: investigations, root causes, CAPA.

Applying functional knowledge and risk-based analysis in risk assessment activities, such as ISO 12100 or ISO 14971.

Exposure to manufacturing environments, especially laboratory or medical devices.

Benefits

Healthcare

Annual Incentive Plan Bonus

Range of Employee Benefits

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)