Offer summary

Qualifications:

Master's degree or PhD in Science, Biomedical Engineering, Diagnostics, or Medical Technology., At least 7 years of experience in the medical device, in vitro diagnostics, or pharmaceutical industry., Minimum of 5 years of medical/scientific writing experience, including writing CERs or PERs., Strong scientific writing skills, attention to detail, and proficiency in literature reviews and data analysis..

Key responsibilities:

Create and maintain Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) in compliance with EU MDR/IVDR.

Collaborate with cross-functional teams to ensure quality standards and regulatory compliance.

Conduct structured literature searches, analyze clinical data, and develop protocols and safety plans.

Support Medical Affairs and Regulatory Affairs in developing regulatory strategies.

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Ready to Think Big and Take Action?

At Haemonetics, we develop innovative medical technology products and services that improve the quality, effectiveness and efficiency of care. We are building a collaborative, performance-driven culture that attracts and develops the best talent.

What are you going to do in this role?

Joining our team, you'll serve as a vital link between clinical expertise and regulatory requirements. Your role will involve crafting scientific and regulatory documents, collaborating with cross-functional teams to ensure adherence to the highest quality standards. Specifically, you'll be responsible for creating and maintaining Clinical Evaluation Reports (CERs) and or Performance Evalution Reports (PER), in alignment with EU Medical Device Regulations (MDR)/ Eu In vitro Diagnostic Regulations (IVDR) and related guidance documents. Your tasks will also encompass conducting structured literature searches, analyzing clinical data, and developing protocols and safety plans.

Additionally, you'll play a key role in supporting Medical Affairs and Regulatory Affairs in devising and executing regulatory strategies. This position will also involve managing vendors, coordinating vendor activities, and supervising temporary staff.

What do you need to succeed in this role:

We're looking for candidates with a Master's degree or PhD in Science (biology, biochemistry), Biomedical Engineering, Diagnostics, or Medical Technology. A minimum of 7 years of experience in the medical device/in vitro diagnostics/pharmaceutical industry, with at least 5 years in medical/scientific writing, is required. Experience in writing CERs (Clinical Evaluation Report)/PERs (Performance Evalution Reports) is paramount.

The ideal candidate will possess a clear, concise scientific writing style, attention to detail, and proficiency in conducting literature reviews and data analyses.

Strong project management skills, the ability to manage multiple writing projects, and excellent language skills are essential (in English and preferably another European language).

What we offer:

Work-life balance environment
Working in an international company in contact with different cultures and nationalities
Take part in building the Scientific affairs department
Career opportunities
Remote policy: 2 days remote/week

If you are interested, Morgane our Talent Acquisition Specialist will be happy to review your application and get in touch with you.

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