Regulatory Affairs Associate

OSSIO is seeking a full-time talented and dedicated individual who is interested in joining its Regulatory

Affairs team. This diverse and challenging role will evolve as his/her technical knowledge and regulatory

affairs experience increases.

OSSIO Ltd. is an orthopedic fixation company committed to transforming the orthopedic experience. The

company is focused on developing and commercializing bio-integrative fixation implants and is based in

the industrial park in Caesarea.

The Regulatory Affairs Associate will be required to gain intimate knowledge of the Company's product

line, including the general scientific technology used to manufacture and test the product, how the

product is used, and how the product is marketed. The Regulatory Affairs Associate will be responsible for

supporting the Regulatory Affairs team in the preparation of the documentation for global regulatory

submissions as required to market new or modified medical devices. The Regulatory Affairs associate will

perform various regulatory affairs activities, including maintenance of regulatory procedures and

documentation, and will help ensure that the company’s product development process addresses all

regulatory requirements, in line with the business objectives. The Regulatory Affairs associate will also

support regulatory activities related to the entire product lifecycle including post-market surveillance and

post market compliance. This full-time position is placed in Caesarea, Israel.

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.

We look forward to you joining our team!

Qualified candidates can submit a cover letter along with their resume or CV in English to [email protected] .