Regulatory Affairs Manager of medical devices

компания "представительство abbott laboratories s.a в рб" responsibilities: work with business unit ra colleagues, emea ra managers, and eu mdr project leaders to obtain required documentation arising from ce marking of medical devices under the eu mdr(medical devices regulation). prepare and submit regulatory files and documentation to regulatory authorities in accordance with local emea country regulatory requirements. where notification of placing on the market is required, support the local commercial organization and emea ra by submitting documentation needed to meet local requirements. liaise with the abbott business unit regulatory affairs / quality assurance / regulatory compliance departments as required to answer regulatory queries and ensure that local processes meet regulatory requirements. liaise with the international ra department staff. implement databases and tracking tools to ensure projects, commitments and reporting requirements are adhered to. provide metrics and feedback to management as required to enable tracking of regulatory activities in support of mdr impact analyses and implementation in emea. support products changes and impacts resulting from the eu mdr, including but not limited to re-branding, tender and reimbursement activities by providing appropriate regulatory and quality documentation as required. support and assist the local emea ra / regional manager to implement to ensure no business interruption arising from the implementation of the eu mdr. requirements for the candidate: educated to degree level in a science discipline or equivalent. experience of working in a regulated environment, preferably in medical devices is required. some experience or knowledge of compliance activities and adherence to quality management systems requirements is desirable. some knowledge or experience of product registration activities and/or european ce marking requirements and basic understanding of the new european medical device regulation would be considered advantageous. knowledge and experience of the application of regulations relevant to the medical device industry. awareness of the role and remit of local regulatory authorities. competent user of microsoft office packages. capability and strong working knowledge of excel is desirable.