Director Regulatory Compliance
Dentsply Ih AB / Kemiingenjörsjobb / Mölndal
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hela Sverige This is a unique opportunity to come and join our Regulatory Compliance (RC) Team where we bring out the best in people in our effort to make a difference. We are currently looking for a Director RC to strengthen our Global Regulatory Compliance Team. About the positionAs Director RC you are responsible for the RC Team within Dental Product Group Implants. You will work in an International environment with skilled people and continuously develop our way of working in order to meet new demanding regulatory requirements and improve time to market.Your key accountabilities are to:Provide support and advice on regulatory pathways and submission strategies for medical devices including software within the organization.Develop strategies and plans for registration of new or changed products in close cooperation with the registration holders in the target countries.Establish and manage the relations with regulatory authorities and notified bodies.Lead and develop your global team, coach your team members in order to grow.Continuously develop the Processes related to Regulatory in order to stay compliance and improve efficiency.Secure Regulatory activities within Development Projects are executed and submitted.Actively work with Sales and Marketing in order to support Market Expansion.Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.Who you are We think you are an analytical person who have the ability to quickly gain understanding of complex regulatory issues and be open-minded for pragmatic solutions. In addition you like coaching and developing the team of highly skilled and committed colleagues. You have a strong drive to achieve goals and ability to maintain a good relation with a broad network in a global business environment.We believe you have:A university degree in engineering or an equivalent professional background.A minimum of 5-8 years professional experience within the Regulatory field, submission of regulatory application within US, EU and rest of the world.Experience from acting as People Manager in an International Environment.Experience from the Life Science sector (odontology, pharmaceuticals, Medical Device or similar).International work experience is desirable.Excellent communication skills as the role requires close contact with several functions.Full command of the English and Swedish language, both written and spoken.Participated to and have experience of Audits from external parties.Good to know This position is located in Mölndal, Sweden and reports directly to the Vice President QA/RC. Travel is expected with approximately 20-30 days/year.For more information, please contact recruiting manager Christina Ericson, telephone +46 31 376 31 22. Please apply no later than June 6, 2019. Please note that we will review applications continuously, so be sure to send in your application as soon as possible.
Publiceringsdatum2019-05-16Så ansöker duSista dag att ansöka är 2019-06-06
Klicka på denna länk för att göra din ansökanFöretagDENTSPLY IH AB
KontorsadressAminogatan 1
Jobbnummer 4793075
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