Job Description

Position Overview

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

This position is based in the United States and falls under the Regulatory Affairs division. You will be part of a team known for their dedication, working in a fast-paced and collaborative environment.

Discover Impactful Work

Join us in a role where you will have a direct impact on ensuring products meet all regulatory requirements. Your work will enable innovations that make a global difference!

A Day in the Life

• Review and provide input on regulatory strategies
• Direct teams on analytical and clinical studies, protocols, and reports
• Ensure compliance with all applicable requirements, including FDA and ISO

Keys to Success

• Proven ability to interpret and apply FDA regulations
• Strong leadership and mentoring skills
• Outstanding attention to detail and organizational abilities

Education

• Bachelor's degree in life sciences or equivalent experience in a related field required

Experience

• 5+ years in regulatory affairs preferred
• Experience with authoring and review of FDA submissions (including: 510(k), special 510(k), DeNovo, Q-submission, 513(g), & PMA)
• Background in medical device, IVD, and/or combination products preferred

Knowledge, Skills, Abilities

• Provides expertise to Regulatory, MSA, clinical, biostatistics, systems, and Research & Development regarding current regulations, requirements and expectations, to include but not limited to: clinical requirements, statistical analysis, analytical requirements, and applicable regulatory requirements.
• Assists with establishing specifications that will align with regulatory requirements along with manufacturing feasibility and scale-up.
• Reports on regulatory risks and communicates any “no-go” or review issues as soon as they are identified or made aware of.
• Reviews project plans to ensure all requirements are identified and planned according to date of need, to meet submission timeline.
• Provides interpretation of new Regulations, Guidance Documents or Standards drafted and/or recognized by the FDA.
• Responsible for validating predicate device determination and device classification.
• Accountable for ensuring the final Intended Use statement is accurate and adds clinical value.
• Able to direct activities and content related to: Risk Management, Cybersecurity, Design Control, User Requirements, feasibility studies, HHEs, Clinical Assessments, and other ancillary requirements related to submissions and post market requirements, as required.
• Leads regulatory interactions with the FDA to expedite query responses and gain clearance.
• Reviews all final submissions to ensure requirements have been met in a manner that avoids unexpected Refuse to Accept, AI Request (hold letter), or withdrawal.
• Provides input regarding the regulatory impact in the change control process.
• Mentors and trains other Regulatory Affairs team members.
• Prepares training that can be applied across teams and divisions to improve understanding of regulatory requirements and the FDA.
• Partners with leadership to develop meaningful critical metrics and feedback.
• Strong communication and social skills

Employment Type

• Full time

Work Schedule

• Standard Office Hours (40/wk)

Environmental Conditions

• Office

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.