南京招聘

Business Segment

Healthcare Global Services

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 Regulatory Affairs Leader - Region may be involved in Pre or Postmarket duties or both. He/she provides subject matter expertise and works with a team of RA professionals to ensure GEHC establishes best practices in premarket & postmarket for RA, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country

Essential Responsibilities

• File / Maintain regulatory deliverables

• Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies

• Support local regulatory authority / notified body inspections as required

• Educate, train, & advise company professionals to ensure compliance with regulatory requirements

• Coach and mentor other RA professionals Premarket

• Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions

• Communicate with Product RA resources to establish regulatory requirements, including clinical trial data.

• Provide RA support as needed to clinical studies to ensure regulatory requirements are met.

• Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required.

• Act as liaison with external regulatory reviewers to gain rapid approval of submissions.

• Work with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.

• Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes. Postmarket

• Reviews new reportable adverse events for country reportability.

 Prepare Recall submissions, localize if applicable.

 Prepare Regulatory Authority responses to inquiries; work with the P&L to ensure accurate response.

 Following PSRB decision, review field action information to determine if reportable in local country.

 Support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.

 Act as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.

 Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L.

• Monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner.

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 up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.

5. Effectively support implementation & management of current regulatory requirements within area of responsibility.

6. Ensure assigned regulatory submissions are accurate, complete and timely.

Qualifications/Requirements

Required Qualifications:

1. Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls

2. Ability to prioritize, plan & evaluate deliverables to established strategic goals.

3. Proven application of analytical skills in a regulatory environment

4. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.

5. Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.

6. Strong problem solving and negotiation skills

7. Ability to work well independently & in a team setting.

8. Prior experience using spreadsheet and presentation software.

9. Must be willing to travel up to 10% of time.

Preferred Qualifications:

1. Advanced degree in scientific, technology or legal disciplines.

2. Regulatory Affairs Certification (RAPS).

3. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

4. Knowledge of Quality Management Systems (QMS)

5. Experience with working across cultures/countries/sites

6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

7. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

8. Experience with adverse event reporting and recalls.

Desired Characteristics

N/A

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。