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Medical Device Software and App Development Specialist

Arcondis Solutions s.r.o.

Place of work
Remote work

Contract type
full-time

Start date
ASAP

Wage (gross)
2 500 - 5 000 EUR/monthThe salary indicated is a tentative estimation and the final salary will be agreed after an interview, once we find out more about your experience and skills.

Information about the position

Job description, responsibilities and duties

Our company is seeking an experienced Medical Device Software and App Development Specialist to lead the development and regulation of medical device software products in compliance with ISO 13485, 21 CFR 820.30, IEC 62304, IEC 82304, IEC 62366, IEC 60601-1, IEC 81001-5-1, AAMI TIR 57, MDCG 2019-16, MDCG 2020-1, and FDA guidance on artificial intelligence and machine learning. The ideal candidate has a deep understanding of software development principles and is knowledgeable about the medical device regulatory landscape.

Responsibilities:

Develop and implement quality management systems and procedures in compliance with ISO 13485 and 21 CFR 820.30.
Manage the design control process for medical device software development in accordance with IEC 62304.
Develop and implement risk management plans in compliance with ISO 14971.
Lead usability engineering efforts in compliance with IEC 62366.
Develop and implement cybersecurity plans in compliance with IEC 81001-5-1, AAMI TIR 57, and MDCG 2019-16.
Plan and execute clinical and performance evaluations in compliance with MDCG 2020-1.
Ensure compliance with SaMD guidelines from the FDA, MDCG, and IMDRF.
Stay up-to-date with the latest developments in medical device regulations, particularly with regards to artificial intelligence and machine learning.
Work closely with cross-functional teams, including software development, product management, and quality control.
Communicate with regulatory bodies and respond to inquiries and requests for information.
Ensure that all documentation and processes are maintained to the highest standards of quality and compliance.

Requirements:

Bachelor's degree in a related field.
At least 5 years of experience in quality assurance and/or regulatory affairs in the medical device industry, with a focus on software-enabled devices.
In-depth knowledge of ISO 13485, 21 CFR 820.30, IEC 62304, IEC 82304, IEC 62366, IEC 60601-1, IEC 81001-5-1, AAMI TIR 57, MDCG 2019-16, MDCG 2020-1, and SaMD guidelines from the FDA, MDCG, and IMDRF.
Experience with artificial intelligence and machine learning in medical device software is a plus.
Strong leadership and communication skills.
Ability to work independently and as part of a team.
Excellent problem-solving and critical thinking skills.
Strong attention to detail and ability to maintain high levels of accuracy.
Ability to adapt to changing regulatory environments and requirements.

Employee perks, benefits

• Company bonus (based on company financial results)
• Referral bonus depending on level of person referred
• Business mobile (also for private calls) and laptop
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for trainings & certifications
• Monthly events in Kosice (Office)
• Home Office upon agreement (or possibility to work from our office in Kosice)
• Flexible working hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey Tickets Discount (HC Kosice home games)

Information about the selection process

Please submit your application in English.
Thank you for applying to Arcondis!

Requirements for the employee

Candidates with education suit the position

Follow-up/Higher Professional Education
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Language skills

English - Advanced (C1)

Advertiser

Brief description of the company

ARCONDIS is in the Top 10 of Consulting Companies in Health Care & Life Sciences in Switzerland. We are a global professional services company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory affairs.

We have been addressing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.

We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation.

Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

We make healthcare better.

www.arcondis.com

Number of employees

150-199 employees

Contact

Contact person: Arcondis Solutions
E-mail: send CV

All company jobs

ID: 4527459 Dátum zverejnenia: 27.2.2023 lokalita: Remote work Pozícia: IT Architect, Quality Control/ISO Manager, Quality Manager, Software Engineer Spoločnosť: Arcondis Solutions s.r.o. Základná zložka mzdy (brutto): 2 500 EUR/month