Job Description

Regulatory Affairs Manager

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.

The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.

Key Responsibilities

• Regulatory Strategy Development: Develop and implement regulatory strategies to achieve timely product approvals.
• Submission Preparation: Prepare and submit regulatory documents to relevant regulatory agencies (e.g., US, EU, Health Canada). Serve as primary point of contact with regulatory body, managing communications and addressing questions or concerns relative to product/project.
• Regulatory Intelligence: Monitor and interpret changes in regulatory guidelines and standards, and assess their impact on the company. Lead Regulatory communications to the broader organization on pertinent regulations updates.
• Compliance Monitoring: Ensure ongoing compliance with regulatory requirements, including post-market surveillance.
• Cross-functional Collaboration: Collaborate with R&D, PPM (product and project manager), QA, marketing, commercial and other departments to integrate regulatory requirements into product development and commercialization.
• Training: Administer training and mentorship to employees for understanding regulatory requirements and standard methodologies.

Education

Bachelor's degree and/or Masters in Biology, Chemistry, bio-engineering or related scientific area.

Experience

5 years of medical device, IVD Regulatory Affairs experience to include either 510(k) or PMA, Notified Body (NB) submissions. Preference would be a former regulatory agency reviewer or staff (e.g FDA submission reviewer). Proficient in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements. Experience in direct communication with regulatory agencies.

Knowledge, Skills, Abilities

Regulatory review experience of promotional marketing materials, press releases, labeling, etc. Strong oral and written communication skills, as well as the ability to provide scientific presentations! Ability to compile data and summarize results. Continuous improvement minded, familiar with balancing Quality and the need for efficiency!

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!

Compensation and Benefits

The salary range estimated for this position based in District of Columbia is $103,100.00$154,700.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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.

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