招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
Business Segment
Healthcare Life Sciences
Role Summary/Purpose
The RA manager, National works with a team of Regulatory Affairs experts to manage the National Regulatory Affairs (NRA) activities for a country. This includes direct responsibility for all local regulatory activities in support of the compliance, registration and promotion of GEHC products in the relevant country. This position works closely with central RA (CRA), the regional RA manager and local and regional commercial groups. A key responsibility for this role is to maintain strong and effe
Essential Responsibilities
?In all activities, to work closely with the regional RA manager.
?To ensure regulatory compliance for Medical Diagnostics products in the relevant market
?To strive that local RA activities reflect and support both local commercial and global business priorities
?To drive the development and strengthening of MDX relationships with regulatory authorities and to act as liaison with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions.
?To provide proactive regulatory advice and expertise to other groups
?To manage the local regulatory activities including;
-Support to central RA for registration and clinical trials,
-Support to local commercial on strategic and operational issues (promotional material, etc)
-Support to central Pharmacovigilance for safety issues and adverse event reporting and to be the local responsible person for Pharmacovigilance, as appropriate to the role
-In cases where there are direct line reports to this position - To manage the recruitment, development, training and activities of internal RA personnel, contractors and consultants. To direct and manage this resource as required to support GE Healthcare business needs.
-To manage the RA budget for market(s) concerned.
?To actively seek to represent GE HC’s regulatory function outside the company (local congresses and trade association meetings, etc.)
?To ensure consistent and quality regulatory practices and procedures which are in line with the rest of NRA and meet the needs of CRA
?To continuously review and put strategies in place to improve existing processes and champion change
The incumbent will have autonomy within the defined role. Decision making responsibility will be defined by the tasks at hand and the business implications of those decisions, including maintenance and tactical level business implications. Where decisions have strategic business implications, these will require approval by the Regulatory Affairs Executive. The incumbent will be expected to interact with all functions within GE healthcare medical diagnostics as necessary.
The incumbent will be expected to interact with external contacts as necessary including maintenance and tactical level communications with Regulatory Authorities. Strategic communication may take place following agreement from the Regulatory Affairs Executive.
Quality Specific Goals:
1.Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2.Complete all planned Quality & Compliance training within the defined deadlines
3.Identify and report any quality or compliance concerns and take immediate corrective action as required
4.Maintain an up-to-date knowledge and understanding of current regulatory requirements within area of responsibility, including pharmacovigilance requirements
5.Maintain an understanding of the GEHC SOPs, relevant Pharmacovigilance SOPs, Working Practices and Good Regulatory Practice guide within area of responsibility
Qualifications/Requirements
1.Bachelor’s Degree in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy
2.Strong analytical skills
3.Ability to work with minimal supervision on projects and activities
4.Ability to prioritize, plan & evaluate deliverables
5.Knowledge & experience conducting scientific, regulatory, legal, or business research.
6.Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
7.Prior experience using spreadsheet and presentation software
8.Experience in regulatory regulatory affairs, and preferably, some experience of negotiating directly with local regulatory authorities.
Desired Characteristics
1.Knowledge of Quality Management Systems (QMS)
2.Ability to work across cultures
3.Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
4.Team-oriented and responsive to customer needs.
5.Familiar with continuous improvement methodologies such as Lean & Six Sigma
6.Ability to represent the regulatory position effectively in order to influence both internally within the company and externally with regulatory authorities.
7.Ability to manage regulatory processes to ensure competitive approvals and maintenance of products.
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