Primary Function:
The Regulatory Affairs Specialist within the Abbott CORE Dx REACH Program team will work on and support the regulatory activities related to both ongoing and planned REACH projects across Abbott and Third Party Manufacturer (TPM) sites.
Major Responsibilities
Education & Competencies
1. Bachelor's degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
2. 2+ years’ experience within a GMP/Biotech/Pharma/Medical Device/IVD regulated industry: experience in Regulatory Affairs would be an advantage.
3. Experience with EU and other international medical device regulations and submissions.
4. Master’s degree in regulatory affairs preferred and may be used in lieu of direct Regulatory experience.
Key Skills:
1. Ability to work in a matrixed and geographically diverse business environment with people from various disciplines and cultures.
2. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
3. Ability to leverage and/or engage others to accomplish projects.
4. Demonstrated experience reviewing and analysing documentation.
5. Must be able to productively generate quality documentation to meet Program timelines.
6. Possess good written and oral communication skills.
7. Strong organisational and follow-up skills, attention to detail, excellent interpersonal skills to deal with multiple business functions and personnel across the organisation, ability to identify obstacles and offer solutions.
Skills:
medical device regulations, GMP, regulation
#J-18808-Ljbffr