Product Safety Compliance Specialist at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Marietta, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Jan, 26

Salary

0.0

Posted On

12 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Project Management, Analytical Reasoning, Interpersonal Skills, Detail Orientation, Manufacturing Processes, Risk Assessment, Technical Documentation, Post-Market Surveillance, Quality Assurance, Communication Skills, Team Collaboration, ISO Standards, Product Lifecycle Management, Investigational Curiosity, Ethical Conduct

Industry

Biotechnology Research

Description

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information We are seeking a professional to join our Laboratory Equipment Division, with preferred locations at or near our manufacturing sites in Marietta, OH, or Asheville, NC. Discover Impactful Work: Our Regulatory Specialist role is responsible for global product compliance in all phases of the product lifecycle. The ideal candidate ensures that our medical and laboratory devices adhere to relevant laws, regulations, standards, and internal policies. Our work focuses on preventing non-compliances, managing risks, and resolving issues when found. A day in the Life: Contribute as a core team member on New Product Development teams by identifying regulatory requirements, coordinating external certification tests, and publishing technical documentation for global markets. Analyze changes to existing products, define regulatory impacts, and resolve gaps through interaction with testing laboratories and revision of technical documentation. Liaise with testing laboratories for product testing, certifications, and site inspections. Collaborate with Quality, Engineering, and other cross-functions in support of Post-Market Surveillance investigations, field activities, reporting, and initiating product improvements. Engage with regulatory agencies and authorities to register products, resolve questions, and manage issues. Research industry standard methodologies and emerging trends in regulatory compliance to implement regulation changes and improvements. Develop, monitor, and improve internal processes, control systems, and tracking of metrics. Perform all job duties per policies and procedures, in a safe and ethical manner. Keys to Success: Education High school diploma or equivalent required. Suggested bachelor's degree in regulatory, project management, or STEM-related field. Experience 3+ years experience in quality, compliance, or verification roles. Exposure to manufacturing environments, especially laboratory or medical devices. 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 such as investigations, root causes, and CAPA. Applying functional knowledge and risk-based analysis in risk assessment activities, such as ISO 12100 or ISO 14971. Knowledge, Skills, Abilities Strong interpersonal and project management skills, with the ability to handle multiple tasks and prioritize effectively. Detail-orientation, analytical reasoning abilities, investigational curiosity, and systems thinking. Self-starter who works well in fast-paced and cross-functional team environments. Functional understanding of manufacturing processes and product engineering change controls. e.g. ISO 9001, ISO 13485 Awareness of international regulations, standards, and requirements for safety, EMC, wireless, environmental, and circular economy topics. e.g. LVD, RED, RoHS, REACH, 61010-1, 61326-1, 62304-1, etc. Exceptional written and verbal communication skills, with the ability to effectively communicate complex compliance concepts to diverse collaborators. Ethical conduct, integrity, and ability to maintain confidentiality of information. Physical Requirements / Work Environment Sit or stand for extended periods on the computer. Use of standard office equipment & Microsoft OS When onsite, exposure to manufacturing environments with noise, dust, and varying temperatures. Interaction with cross-functional and global teams. Adapt to changing priorities in a fast-paced environment. Travel domestically and internationally up to 10%. 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. As 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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Responsibilities

The Regulatory Specialist is responsible for global product compliance throughout the product lifecycle, ensuring adherence to laws, regulations, and internal policies. This role involves collaborating with cross-functional teams and regulatory agencies to manage compliance risks and resolve issues.