Sr. Regulatory Affairs and Human Factor Specialist
16.05.2019 | Employee | 100%

Bracco Injeenering SA is a company of the international Bracco Group (www.bracco.com).  

Bracco Group :  Bracco is an international Group active in the healthcare sector through Bracco Imaging (diagnostic imaging), ACIST Medical Systems (medical devices and advanced imaging agents injection systems), and the Centro Diagnostico Italiano diagnostic clinic in Milan. It has more than 3,450 employees and annual total consolidated revenues of around 1.3 billion euros, of which 87% from international sales, and it is present worldwide. In the Research and Development area, the company invests approximately 9% of reference turnover in the imaging diagnostics and medical devices sectors and has a portfolio comprising over 1,800 patents. Its subsidiary Bracco Imaging is one of the world’s leading companies in the diagnostic imaging field :X-Ray Imaging (including Computed Tomography-CT), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound, and Nuclear Medicine. The Company operates in over 90 markets: in North America through Bracco Diagnostics Inc. USA headquartered in Princeton, NJ, and with an affiliate in Montreal (Canada); in Europe, with offices in all major countries; in Japan (BRACCO-EISAI). The Company also operates in South America, South Korea and China through its 70% controlled Joint Venture, Bracco Sine Pharmaceutical Corp. Ltd

Bracco Injeneering:  In July 2011, the Bracco Group acquired Swiss Medical Care to strengthen and complete the portfolio of automated system for the administration of contrast media with technological advancements such as CT Exprès.

 

Effective December 17, 2012, SMC has changed its name to BRACCO INJENEERING S.A., the new Business Unit of Bracco Imaging SpA.

 

The name BRACCO INJENEERING denotes a company committed to developing the best-in-class integrated injection solutions with a strong heritage in research and innovation. It provides quality solutions for state-of-the-art radiology centers, offering proven injection technology, built on Bracco Imaging expertise. BRACCO INJENEERING S.A. is based in Lausanne.  

Sr. Regulatory Affairs and Human Factor Specialist

Position summary:

Manage Regulatory Affairs activities for informatics program and human factor activities for all new and existing product development, including development of regulatory requirements/strategies. Support BRACCO INJENEERING Regulatory department with international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards. Participate in Regulatory activities associated with product field corrective actions as required and ensure that product approvals are properly maintained and product re-submissions are properly managed. Exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.  The position will be interfacing with regulatory bodies, third party consultants, marketing, R&D team and management, and assist in developing ideas for solutions consistent with our product development roadmap.

 

Duty & Responsibilities / Percent of Time:

Regulatory Affairs / 60%:

  • Collaborate with R&D and Sustaining team in the development of new and existing devices in the framework of the Informatics program for all regulatory activities (premarket). This activity includes development of regulatory requirements and strategies, preparation of documents etc.
  • Support of the team in charge of recordings devices worldwide as part of the informatic program.
  • Cordinates Post Market vigilance reporting and resulting actions for Informatics program.
  • Manage the maintenance of Technical Files such EC technical Files, 510(k) for Informatics program.
  • Support maintenance of Risk Management File with Risk Management Coordinator.
  • Participates during notified body audit and other inspections.
  • Establishes procedures for maintaining compliance with regulatory standards.

 

Human Factor / 40%:

  • Manage Human Factor Activities for all BRACCO INJENEERING devices in collaboration with third party companies.
  • Act as an expert in Human Factor activities for BRACCO INJENEERING and support sustaining and new product development project to identify needs in terms of human factor requirements and activities.

 

Required Skills - Qualifications (Knowledge, Skills & Abilities):

Minimum:

 

  • Bachelor degree in Science or Engineering.
  • Minimum of 5 years’ experience in Regulatory Affairs.
  • Minimum of 3 years’ experience in Human Factor.
  • Minimum of 3 years’ experience in Regulatory Affairs with software knowledge (IEC 62304, HIPPA, GDPR etc.).
  • Minimum of 5 years medical device industry experience including strong 510(k) submission experience, EU CE Mark submissions, Health Canada submissions, and international market submissions.
  • Strong working knowledge and experience with quality systems regulations and guidelines, ISO, GMP, Medical Device Directive (MDD) and FDA regulatory requirements.
  • Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
  • Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions.
  • Skill in determining alternatives that would correct a situation to comply with standards and regulations.
  • High level of planning and organizational skills desired.
  • Desire knowledge of medical terminology.

 

 

 

 

 

 

 

 

 

 

 

Preferred:

 

  • RAC Certification
  • Five years or greater of experience in medical device industry and software/informatics technologies

 

 

 

 

Other:

 

  • Requires intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons.
  • The work is detail oriented, often with multiple priorities. 
  • The environment is deadline sensitive.  Frequent high-pressure situations.
  • Travel requirements are minimal.

What we offer:

  • An international environment and being in contact with local and HQ Managers.
  • A unique opportunity to work independently and autonomously.

Job Location: Bracco Injeneering - Lausanne - Switzerland

Position Type: Full-time

If you recognize yourself in this profile address your complete application (CV , Cover Letter, Work certificates and diploma)

16.05.2019
Employee, 100%

Required minimum profile

  • Bachelor degree in Science or Engineering.
  • Minimum of 5 years’ experience in Regulatory Affairs
  • Minimum of 5 years medical device industry experience including strong 510(k) submission experience, EU CE Mark submissions, Health Canada submissions, and international market submissions.
  • Minimum of 3 years’ experience in Regulatory Affairs with software knowledge
  • Swiss resident or with a working permit B/C

Contact

Bracco Injeneering
Avenue de Sévelin 46
1004 Lausanne
Bracco Injeneering
Avenue de Sévelin 46
Lausanne

Industry

Biotechnology / Chemistry / Pharmaceutical
Benefits (5)
Fruits

Fruits

Free fruits each weeks
Parking

Parking

Free underground parking for all our employees
Accessible

Accessible

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