Offer summary

Qualifications:

Strong educational background in Lifesciences, MDR or IVD experience., Proficiency in English; knowledge of additional languages like German, Dutch, or French is a plus., In-depth knowledge of global regulatory affairs and quality management systems, particularly ISO13485 and MDR., Excellent communication, organizational, and project management skills..

Key responsabilities:

Oversee and manage quality and regulatory affairs within the organization.

Ensure compliance with industry and global regulatory standards.

Develop and implement quality management systems (QMS) and conduct audits.

Liaise with internal and external stakeholders on regulatory affairs and provide training to staff.

Job description

Specialist Quality Management & Regulatory Affairs Europe
Somnomed Medical Devices Europe

About Our Client

SomnoMed, founded in 2004, is an Australian Stock Exchange-listed medical device company operating in 28 countries. Headquartered in Sydney, Australia, with offices in Europe and the United States, SomnoMed focuses on the development and production of clinically proven medical devices for the treatment of obstructive sleep apnea (OSA). More than 950,000 patients worldwide with mild to moderate OSA have been successfully treated with SomnoDent MRAs.

Job Description

Overseeing and managing quality and regulatory affairs within the organisation.
Ensuring compliance with industry and global regulatory standards.
Developing and implementing quality management systems (QMS).
Liaising with internal and external stakeholders on regulatory affairs.
Conducting audits and inspections to maintain quality assurance.
Conducting trend analysis and Post Market Surveillance (PMS) activities.
Providing training and guidance to staff on quality and regulatory matters.
Keeping up-to-date with changes in regulatory legislation and guidelines.
Preparing and submitting regulatory documents.
Actively contribute to the upcoming implementation of a global eQMS.

The Successful Applicant

A Successful QARA Specialist Should Have

A strong educational background in Lifesciences, MDR or IVD experienced.
Proficiency in English. Other language, such as German, Dutch, French, is a plus.
In-depth knowledge of global regulatory affairs and quality management systems, with a mandatory emphasize on ISO13485 and MDR.
Excellent communication, organisational and project management skills.
Strong problem-solving and decision-making abilities.
The ability to work well in a team and independently.

What's on Offer

Our Client Offers You

A competitive salary range
The opportunity to work in a supportive and professional environment, adding value to a global QARA team and the entire organization.
A position that enables work on remote, and punctually, travels to our European entities
The chance to make a real difference in the medical device industry.

Contact: Rikkert Kempen

Quote job ref: JN-032025-6693541

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