Director Quality Assurance/Regulatory Affairs

BMD - Bio Medical Device | Oslo

Director Quality Assurance/Regulatory Affairs

Bio Medical Device AS (BMD) is a Norwegian company, founded in 2018, with the objective to develop and commercialize a new revolutionary medical device technology intended for treating patients with urinary stress incontinence. BMD is set up as a company to develop Incontinence Valve System (IVS) into a global commercial medical device, serving multiple incontinence related indications. Our lead investors are Codee Holding and Planet 9 Venture, with founders and employees as key owners. BMD´s vision is to restore urine control for the millions of men and women suffering from incontinence. Our user-friendly solutions will allow patients to enjoy their lives without urine leakage. Our mission is to develop a revolutionary medical device to improve the health and quality of life of people suffering from urinary incontinence. BMD is a company thriving on shared values, with patients at the center of all we do. Working together, these values allow us to develop products and services that genuinely will make a difference to people’s lives around the world. For more information, please visit www.bmdevice.com 

Are you passionate about Quality Assurance & Regulatory Affairs?

Do you want to succeed in an exciting start-up company?

Do you want to contribute to the transformation of healthcare?

To achieve our vision and to take the next step in our journey to develop

our unique device we are recruiting a:

Director Quality Assurance/Regulatory Affairs

The main objective is to establish and manage Quality Assurance and Regulatory Affairs at BMD and to be BMD’s Management representative and Person Responsible for Regulatory Compliance (PRRC). In addition, you will secure a coordinated regulatory strategy for BMDs products, aligned with BMDs overall commercial strategy as well as be BMDs main contact in communication with European Competent Authorities/Notified Bodies and other regulatory authorities such as FDA. Furthermore, you will participate as QA/RA resource in current and new project opportunities.

Responsibilities includes:

  • Overall responsibility for establishing, implementing, and maintaining the BMD QMS as per ISO 13485, regulation (EU) 2017/745 Annex IX sections I and III, 21 CFR Part 820 and 21 CFR Part 11
  • Report status and performance of the QMS to top management as Management representative
  • Ensure quality and regulatory operations including:
  • Control of suppliers
  • Feedback management (Complaints, CAPA, NC etc)
  • Change management
  • Incident reporting
  • Post market surveillance
  • Vigilance
  • Registrations of medical devices and technical documentation
  • Internal and external audits
  • Control risk management activities per ISO 14971
  • Lead communication with external QA/RA partners
  • Secure all applicable regulations, standards and guidance documents are identified and followed
  • Provide advice to secure a coordinated Europe/USA product development and commercialization in line with Company strategy
  • Secure BMD staff is appropriately trained – implement training and onboarding system as needed
  • Budget and resource management responsible for QA/RA
  • Member of the leadership team

Qualifications:

  • Relevant University degree
  • Minimum 5 years of industry experience with positive track record in quality management, regulatory affairs, and product life-cycle management, including decision making
  • Experience in leading small and mid-size teams
  • Ability to travel internationally as needed
  • Advanced in English orally and in writing

Who are you?

As a person, you are reliable, unpretentious and professional. You are structured, organized and you understand and analyze complex matters quickly in your way of working and have a clear focus on bottom-line and execution. You are result-oriented and not afraid to roll up your sleeves in everyday work. You are a good team player and you value cooperation and always show responsibility for your own work and for contributing to a good collaboration with others. You have a strong communicative ability and are fluent in both Swedish and English in speech and writing. You have an entrepreneurial mindset with a high interest to work in a small and passionate team. You inspire others through your dedication and your passion, and you create a culture of ownership and commitment in your environment.

To apply

This recruitment is handled by H&P Search & Interim. Please contact us for more information. Alternatively, you can apply directly by uploading your resume and sending us an email.

We look forward to your application!

H&P Search & Interim

Torbjörn Ströberg, torbjorn.stroberg@hpsearch.se, tel 0703-778 774

Catharina Bergold, catharina.bergold@hpsearch.se, tel 0702-179 879

Johan Walde, johan.walde@hpsearch.se, tel 0761-870 612