Offer summary

Qualifications:

A degree or equivalent qualification in chemistry, biochemistry, or biological sciences., Proficiency in oral and written English is essential., Experience in Medical Device Vigilance and familiarity with EEA MEDDEV, MDR, IVDR, and FDA regulations is required., Knowledge of EU and UK Quality Standards and Regulatory requirements for Medical Devices and IVDs is necessary..

Key responsabilities:

Oversee post-market surveillance and vigilance activities for medical devices in the EEA and EMEA regions.

Interface with National Competent Authorities and Notified Bodies, acting as Vigilance Coordinator.

Advise the Commercial Operations Team on IVDs and Medical Devices, coordinating post-market information collection.

Collaborate with Global QA and RA colleagues to ensure quality improvements and address local quality-related actions.

Job description

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.

At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster.

Our Values include:

Resilient Growth Mindset
Executional Excellence
Courageous Leadership
Inclusive Collaboration

We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.

Job title: Global Vigilance Manager

About the opportunity: As Global Vigilance Manager, you'll lead post-market surveillance and vigilance activities for medical devices across multiple regions. You'll interface with regulatory bodies and affiliates, support global vigilance efforts, and coordinate with the APAC team to meet local requirements. Additionally, you'll advise on commercial operations and collaborate with global QA and RA colleagues to ensure quality improvements.

Location: Poland – remote

What you will be doing:

Overseeing post-market surveillance and vigilance activities for a Medical Device Manufacturer in the EEA and EMEA regions.
Interfacing with National Competent Authorities, Notified Body (BSI), and EEA Affiliates.
Acting as Vigilance Coordinator, collaborating with the APAC team to meet local authority requirements.
Contributing to activities related to FSCAs and CAPA.
Advising the Commercial Operations Team on matters related to IVDs and Medical Devices, and coordinating the collection and analysis of post-market information on competitor recalls.
Collaborating with Global QA and RA colleagues, providing guidance for local quality-related actions, and ensuring improvement priorities are identified and addressed.

What you need for success:
Required Skills:

A degree or equivalent qualification, preferably in chemistry, biochemistry, or biological sciences.
Proficiency in oral and written English.
Experience in Medical Device Vigilance, EEA MEDDEV, MDR, IVDR, and FDA.
Proven experience in interacting with Regulatory Agencies.
Knowledge of EU and UK Quality Standards and Regulatory requirements for Medical Devices and IVDs.

Desired Skills:

Familiarity with ISO 13485.
Understanding of Asia Pacific Quality Standards.
Experience as a Qualified Lead Auditor.

What we can offer you:

Friendly team and supportive environment
Contract of employment, one-time home-office set-up allowance
Lunch Card - 300 PLN monthly
Annual bonus plan
Life insurance, private medical care – Luxmed VIP package with dental coverage
Pension Plan (PPE), Employee Assistance Program
Multicafeteria: Sport Card, Cinema tickets etc.
Access to LinkedIn Learning platform with training courses
Language learning platform online - eTutor
Access to audiobook platform

TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.

Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.

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