RA - QA Senior Manager (m/f/d)

Standort Land Branche Referenz
Freiburg im Breisgau International Medizintechnik SF1442

Based on outstanding performance our client is developing steadily and strongly. Our client is one of the most innovative medical device companies and market leader presenting a disruptive technology for multiple surgical disciplines. This unique selling proposition offers employees the best basis to deliver performance and develop a solid career. It is preferred to fill leading responsibilities internally. Start working with one of the best global leading medical device companies with its growing DACH HQ in Freiburg. Growing strongly our client developed a solid and sustainable HR strategy paired with unique working conditions. In the RA - QS Team your main scope of functions will be: Management of regulatory operations, regulatory registrations/filings, post-market surveillance, QMS, liaison with Corporate & EMEIA RA-QA teams, advocacy with government bodies and manufacturer associations across Germany and Austria. Ensure proper liaison with sales, marketing and service teams as well as all support functions.

Jetzt bewerben

Ihre Aufgaben

  • Join the leadership team to ensure compliance of all of our customers activities with applicable regulation; guide and influence operational decisions accordingly
  • Identify, develop and implement processes to support compliance activities related to post market surveillance, including complaint management, vigilance reporting and field actions
  • Represents our customer with competent authorities (eg BfArM) and manufacturer associations (eg BVMed) to ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures, to carry out our customer advocacy activities to defend and promote company policy objectives before regulatory and policy making bodies, to maintain a constructive relationship with health authorities through frequent and transparent dialogue
  • Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
  • Develop & implement regulatory strategy to obtain regulatory clearance and enable commercial market opportunities of new products or existing portfolio
  • Act as Germany/Austrian Subject Matter Expert with regards to local regulation; support RA intelligence and regulatory surveillance process
  • Act as a liaison between our customer to Regulatory affairs and quality compliance EMEIA and corporate headquarters and other international sites in support of regulatory and quality system activities

Additional activities
  • Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, audit
  • Provide support to clinical activities
  • Other projects may be assigned as necessary
  • Travel: up to 20%

Ihr Profil

  • At least 10+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
  • A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
  • Deep knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, ISO 13485:2016
  • Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
  • Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
  • Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Language: Fluent English and German

Preferred Knowledge, Skills, and Experience:
  • Lead auditor certification for ISO 9001, 13485 and knowledge of WW regulations
  • Good knowledge of medical device reprocessing/sterilization or refurbishment requirements
  • Team management experience of small team size associated with goals objectives definition / people development.

Ihre Chance

  • Unique perspectives and development opportunities inside a top global medical device player
  • Our client consistently develops their employees to ensure they may have successful careers by improving patient outcomes around the world
  • Selling clinical value and impact
  • Perspective to change the future of surgery
  • Outstanding performance based salary system. Rewarding.
  • Excellent social benefits

Please send your CV and cover letter in English!

Haben wir Ihr Interesse geweckt? Dann freuen wir uns, Sie kennen zu lernen!

Jetzt bewerben
Diese Seite teilen

Ihr Personalberater

Gerne beantworten wir Ihre Fragen rund um die Stelle und zur Bewerbung:

Bild Siegfried Faix

Siegfried Faix

Managing Partner

T +49 761 888 51 23 10
F +49 761 888 51 23 99