Team Leader Regulatory Services

True to the vision “We drive innovation to improve people’s lives”, the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.

Hamilton Central Europe is located in Timisoara, Romania and develops and produces microliter syringes, needles, dosing pumps, pipetting modules and accessories for analytical and research laboratories, as well as accessories for medical devices used in intensive care units. In addition, we provide financial accounting services for the Hamilton companies.

Job Description:

• Have good knowledge of leadership principles
• Deliver multi-year, (multi)-team goals
• Coordinate organization units which are largely homogeneous in nature and objective
• Participate in the company day-to-day operations (hands-on mindset)
• Disciplinary and professionally manage the assigned organizational unit, in particular promotion and further development of employees with special skills
• Handle more complex tasks, projects and larger, diverse or several teams under his/her leadership
• Coordinate the core tasks and individual teams in different topics
• Lead a team or more teams with special goals and complex tasks (e.g. customer support)

Professional experience & skills desired to have:

• Education:
  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field.
  • Advanced degree or regulatory certifications (e.g., RAC, ISO 13485 Lead Auditor) are advantageous.
• Experience:
  • Minimum of 5 years of experience in Regulatory Affairs, Vigilance, or Quality Assurance within the medical device industry.
  • Proven leadership experience in managing or supervising a team.
  • Strong knowledge of ISO 13485, US FDA 21 CFR 820, EU MDR 2017/745, and MDSAP requirements.
• Skills:
  • Excellent communication and leadership skills.
  • Strong organizational and project management abilities.
  • Analytical mindset with attention to detail and problem-solving skills.
  • Proficiency in regulatory and quality management systems.
• Language Requirements:
  • Fluency in English is mandatory.
  • Knowledge of German or other European languages is a plus.

How to apply:

Send us your resume at jobs.hce.ro@hamilton-ce.com or via the "Apply" button below.

Obtain more information via telephone +40356 635 056 / +40725 707 005

Only suitable candidates will be contacted for interview. Please note that your resume will be entered in our database and may be used in further recruitment projects.