南京招聘

Business Segment

Healthcare Life Sciences

About Us

GE (NYSE: GE) works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com

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;
oSupport to central RA for registration and clinical trials,
oSupport to local commercial on strategic and operational issues (promotional material, etc)
oSupport to central Pharmacovigilance for safety issues and adverse event reporting and to be the local responsible person for Pharmacovigilance, as appropriate to the role
oIn 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.
oTo 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.

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。