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Natural Scientist - Regulatory Affairs, OTC Medical Devices (m/f/d)

Location
Essen, Nordrhein-Westfalen
Job Type
Permanent
Posted
3 Nov 2021
bitop is an internationally operating, typical medium-sized and owner-managed company. Our DNA is "Extremolytes for life" - it drives us to make the world and its inhabitants healthier, happier, and more beautiful. To achieve this, we use the most modern and sustainable biotechnology to produce unique, natural cell protection molecules, so-called Extremolytes.
Our main business is the development and marketing of extremolyte-based OTC medical devices for various indications like Allergy, Cough & Cold, Respiratory Diseases, Dermatology, and others. We sell our medical devices (class I - II) as B2B white label products to our national and international partners within the Consumer Health Care and Pharma Industry.

Market understanding, innovation strength and responsibility towards our customers and employees have made us the market leader in our field. We are a motivated team of businesspeople, scientists, engineers, production professionals and committed all-rounders who share entrepreneurial thinking and a strong passion for Extremolytes and their potential.

To support our Regulatory Affairs Team for OTC Medical Devices, we are looking for a qualified and ambitious
Senior Regulatory Affairs Manager (m/f/d)
the preparation of international approval documents for our substance based medical devices (OTC, Class I to II) and the corresponding European and international registration process
the review and approval of product documents
the maintenance of bitops regulatory compliance
you are one the contact person for our notified body (TÜV Rheinland) and internal/external customers on regulatory topics
you are the PRRC (§15 MDR) for regulatory aspects (technical documentation)
this position entrusts you with leading responsibilities in interdisciplinary projects

university or college degree in the field of natural sciences, biotechnology, pharmacy, veterinary medicine or medicine
min. of 1 year's professional experience in regulatory affairs for OTC medical devices (class I-II) and with the health authorities at national and international level
profound knowledge of EU medical device legislation (including 93/42 / EEC; MDR) and DIN EN ISO 13485 and other international regulations
ability to assess regulatory risks/benefits and applicable guidance
business-fluent written and spoken English and good German skills
ability to work independently in a structured, pragmatic way
confident demeanor and excellent communication skills

home office, flexible working hours and an attractive salary
international customers and varied tasks
a committed and inspired team, that cherishes the collegial, highly motivated atmosphere within bitop
flat hierarchies with short communication channels
a culture that encourages initiative, independent thinking, and creativity and rewards enthusiasm
bitop yoga classes (online), company events
company pension scheme
company canteen with subsidized lunch, free drinks, fresh fruit, and coffee bar
pet-friendly, modern working environment in an attractive setting
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Details

  • Job Reference: 413639818-2
  • Date Posted: 3 November 2021
  • Recruiter: bitop AG
  • Location: Essen, Nordrhein-Westfalen
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Permanent