Head of Medical Affiars

2 weeks ago

Mölndals kommun, Sweden Wellspect HealthCare Full time

Wellspect Healthcare is a leading global provider of innovative medical devices that help people suffering from urinary retention or chronic constipation. More than 1 000 employees around the world are dedicated to making a difference to people who need our products and services. Wellspect is one of the worlds’ leading manufacturers of intermittent urinary catheters, with LoFric as the most known brand. As a help to those with chronic or severe constipation Wellspect has developed what likely is the world’s most advanced irrigation system, Navina, combining a high degree of user convenience, clinical effectiveness and connectivity into one smart system. Wellspect strives to become climate neutral and leave the smallest possible environmental footprint. The company, with headquarters in Mölndal, Sweden, is present in more than 30 countries, and part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental technologies. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit and for more information.

Head of Medical Affairs

Do you want to be a part of developing and commercializing products for a company that is committed to make a difference every day? Join Central Marketing as Head of Medical Affairs and influence on our business moving forward.

You will lead a diverse team of highly skilled people making sure our products go to market with high safety in combination with strong strategic decision making and a commercial mindset.

About the position

As our Head of Medical Affairs you drive the clinical strategy and oversee, develop and execute clinical trials to support approval and commercialization of Wellspect’s medical devices. You will be part of the Central Marketing Management Team and report into our Vice President Central Marketing. This position has the responsibility to substantiate clinical and health economics claims while implement the safety and efficacy requirement for current and proposed products.

Additionally, you will drive clinical perspective to project teams and other functions such as Quality and Regulatory Affairs, R&D and Product Marketing. Clinical trials and analysis may be global and will include those designed to support regulatory submissions, reimbursement and marketing activities. This position is responsible for identifying, developing and /or evaluating new technologies and solutions in scientific disciplines outside of the core therapy areas.

Other Responsibilities

  • Carrie out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work.
  • Responsible for clinical and health economic evidence to contribute to registrations in different geographies and countries.
  • Establishes and maintains successful collaboration and partnerships with third party vendors (e.g. CROs), study investigators and site research personnel to facilitate successful execution of clinical studies.
  • Support development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
  • Ensures the Medical Affairs team maintains a continuous state of audit readiness.
  • Implement legal requirements of contracts, non-disclosure agreements, and financial agreements in clinical programs.
  • Clinical Technical documentation such as Clinical Evaluation Plan/Report, Post-Market Clinical Follow up Plan/Evaluation report, State Of The Art and Literature Searches.
  • Health economy support to Marketing and Sales as well as to new product development projects.

Who you are

You have a firm clinical background and a sense for commercial drivers, preferably experience from MedTech industry or Life Science. We think you are an energetic and analytic person who likes to take initiatives and decisions. You are open for challenges and enjoy working together with highly skilled and committed colleagues where every day makes a difference. You strive in the interface of clinical science, health economics science and commercialization of products impacting people´s life to the better.

Background / Qualifications:

  • At least Master´s Degree in the Sciences or Medical discipline, PhD preferred.
  • Demonstrated ability to understanding and interpret clinical data and literature.
  • 4 - 6 years of industry experience in managing medical device clinical studies and clinical evaluations.
  • Previous experience managing teams.
  • Knowledge of ISO-14155, FDA and MDR requirements.
  • Excellent communication, organizational and people management skills.
  • Independent, proactive, confident and self-directed individual.

Good to know

We have a culture of team spirit, where sharing knowledge and finding new ways to tackle challenges together is the key. Joy is our spice

This position is located at our headquarter in Mölndal, Sweden and will involve some travelling to build and maintain relations.

Please apply no later than February 28th, 2024. Please note that we will review applications continuously, so be sure to send in your application as soon as possible.

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