$110,000 - $140,000
21 days ago
Regulatory Affairs Specialist
This is an opportunity to join a highly successful established consultancy located just north of the Boston MedTech hub. This organisation have been providing pragmatic and efficient solutions to clients for over two decades, with their Regulatory & Clinical services highly sought after across the Medical Device and IVD space.
- Engage in both premarket and post market activities, learning from the leadership team in the process about best practices and strategizing these tasks.
- In accordance with EUA requirements, will proactively identify and complete regulatory duties such as:
- Product administration and distribution of EUA products
- Provide information to FDA in a manner that aligns with timelines and maintain the records of these communications.
- Understanding advertising and promotional material compliance
- Maintain all EUA records in a highly organized matter
- Work collaboratively with internal project teams and stakeholders to proactively manage details related to the EUA products.
- Prepare and present regular updates to management and key stakeholders.
- A minimum of 3 years of responsibility in medical device regulatory affairs; with a background in IVDs a preference. Comparable experience in Biologics / Pharma will be considered.
- Minimum of a Bachelor’s degree in a medical, scientific, or technical discipline.
- Excellent written and oral communication skills.
- Highly organized with strong attention to detail.
- Ability to work in a complex, face-paced environment.
- Action-oriented and attentive to deadlines
- Must be legally authorized to work in the United States without required sponsorship
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.