Primary Function:
The Regulatory Affairs Specialist will work on and support regulatory activities for REACH projects across Abbott and third-party manufacturer sites.
Major Responsibilities
* Bachelor's degree in a scientific field, such as biology, chemistry, or pharmacy.
* 2+ years of experience in a GMP/Biotech/Pharma/Medical Device/IVD regulated industry.
* Experience with EU and international medical device regulations and submissions is required.
Key Skills
* Ability to work in a diverse business environment with people from various disciplines and cultures.
* Strong organizational and follow-up skills, attention to detail, and excellent interpersonal skills.
* Ability to identify obstacles and offer solutions.
Responsibilities Include:
* Reviewing and analyzing documentation.
* Generating quality documentation to meet project timelines.
* Communicating effectively with multiple stakeholders.
Skills Required:
* Knowledge of medical device regulations and GMP regulations.
About the Role:
This role is responsible for ensuring compliance with regulatory requirements and supporting the development of new products.
The Ideal Candidate:
* Has a strong understanding of regulatory affairs and medical device regulations.
* Is able to work independently and as part of a team.
* Is organized and able to prioritize tasks effectively.