Regulatory Affairs Specialist

Skills

Description

Requirements

• 1-3 years of relevant experience in Regulatory Affairs within the medical device industry.

• B.Sc. Degree in Life Science or related field. (M.Sc. preferred)

• Excellent written and verbal communication skills in the English language.

• Strong organizational skills with attention to detail and accuracy as well as good analytical skills.

• Ability to conduct thorough research for global regulatory submissions.

• Ability to work well under pressure.

• Ability to multi-task to meet strict deadlines.

• Computer literate with proficiency in Word, Outlook, Excel, and Adobe PDF.

• Mental flexibility to solve complex problems.

• Ability to work independently and as part of a team.

• Ability to maintain high ethical standards of integrity and quality.

• Knowledgeable about current Good Manufacturing Practices (cGMPs), Good Clinical Practices

(GCPs), and Good Laboratory Practices (GLPs).

• Enthusiasm and willingness to learn are more important than work experience. More experienced

candidates may be considered.