Real Staffing

QA/RA Manager

Location: Wallonia, Belgium
Salary: -
Job Type: Contract
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KEY RESPONSIBILITIES

  • Overseeing the implementation of a Quality Plan, Quality Management System, Quality Management Policy, Quality Goals, and applicable regulations and internal standards
  • Assure site and business is properly prepared for external and internal compliance inspections/audit
  • Identify and report any quality or compliance concerns and take immediate corrective action as required
  • Having the authority to issue concessions, stop production, make decisions about people and budget accountability
  • Assure business goals are established and met for compliance, training, CAPA, complaints and production process control across sites/regions.
  • Maintains product quality by enforcing quality assurance policies & procedures and industry requirements; collaborating with other members of management to develop new product and engineering designs.
  • Lead team to design, implement, and improve Supplier Quality processes ensuring Supplier Quality compliance to the QMS, regulatory requirements and overall process improvement.
  • Develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements
  • Lead and support improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation.
  • Liaise with external regulatory bodies to guide input into regulatory strategies
  • Educate, train, & advise company professionals to ensure compliance with RA requirements.
  • As appropriate, recruit, mentor, coach & train direct and indirect reports on activities within areas of responsibility

Job description

  • Proven application of analytical skills in a regulatory environment
  • Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, etc.
  • Demonstrated project management skills: ability to prioritize, plan, evaluate & execute deliverables for established tactical goals
  • Ability to influence and make recommendations at multiple levels of the company
  • Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements.

REQUIRED QUALIFICATIONS

  • Bachelor's Degree & minimum of 5 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies
  • Demonstrated experience operating in a highly regulated environment

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