Regulatory Affairs Project Manager

Job Description

As RA Project Manager, you will be responsible for new product submissions for regulatory

approval in the US, Europe, Japan, China, Brazil, Australia, and more.

SCOPE & RESPONSIBILITIES

• Preparing, coordinating, tracking, and following up on approvals for medical device

submissions in the US (510k, Denovo), Japan, China, Brazil, Australia, and more.

• Preparation and management of EU MDR technical documentation submissions.

• Oversees CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall.

• Participate in regulatory inspections and audits.

• Prepare regulatory assessments for design changes.

• Developing labeling according to applicable regulatory requirements

REQUIREMENTS

• Degree in Biomedical Engineering / Biotechnology

• 2-5 years of relevant previous experience in regulatory affairs of medical devices (preferred)

• English - high level (both written and spoken).

• Excellent teamwork ability and interpersonal skills.

• Service oriented.

• Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision.

• Strong attention to details.

• Computer skills (Microsoft Word, Excel, PowerPoint)