Regulatory Affairs Specialist

Job description / Role

Role Summary:

The Regulatory Affairs Specialist - Region may be involved in Pre or Postmarket duties or both. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket and postmarket support. He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country

Essential Responsibilities:

- File and maintain regulatory deliverables
- Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
- Support regulatory inspections as required
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes
- Premarket
- Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions
- Communicate with Product RA to establish regulatory requirements, including clinical trial data
- Complete specific country testing and work with Product RA; arrange for test devices and support as needed
- Provide RA oversight to clinical studies to ensure regulatory requirements are met
- Partner with Product RA 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 Product RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license
Postmarket
- Monitor external information for incidents or issues that may involve GEHC products; communicate information internally in a timely manner
- Liaise with relevant personnel to ensure appropriate, timely input is provided for postmarket reports
- Review field action information to determine if reportable in local country
- Liaise with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports

Requirements

Qualifications/Requirements:

Required Qualifications:
Bachelor's Degree (or internationally recognized equivalent) 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 and minimum of 5 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations or equivalent knowledge or experience
- Strong analytical skills
- Ability to work in a team environment with minimal supervision on projects and activities
- Ability to prioritize, plan & evaluate deliverables
- Knowledge & experience conducting scientific, regulatory, legal, or business research
- Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
- Experience using spreadsheet and presentation software

Preferred Qualifications:

- Advanced degree in scientific, technology or legal disciplines
- Regulatory Affairs Certification (RAPS)
- Experience in a medical device or pharmaceutical industry
- Knowledge of Quality Management Systems (QMS)
- Experience working across cultures/countries/sites
- Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
- Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
- Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies

Desired Characteristics:

- 4-5 minimum experience years should be holding Bachelor degree such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy or equivalent knowledge or experience

About Us: GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
Learn More About Careers at GE

Learn More About GE Healthcare

GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, and according with all local laws protecting different status.

Follow us on Twitter , join our LinkedIn Group or become a fan of our Facebook page. Receive job and event notifications by becoming a member of the GE Talent Community . Stay up to date on what's happening at GE around the globe by checking out the GE Careers Blog .

About the Company

GE is a diversified technology, media and financial services company, dedicated to creating products that make life better. From aircraft engines and power generation to financial services, medical imaging, television programming and oil and gas, GE operates in more than 100 countries and employs over 300,000 people worldwide.

GE's Oil & Gas business is a leader in the development and delivery of advanced product and service offerings for the global oil and gas industry. As a consequence of the rapid expansion of its technology base, GE's Oil & Gas is capable of addressing the largest and most complex engineering and application challenges entirely from its own worldwide resources. So whether it's the world's largest LNG compression trains, re-injection of high sulfur gas, enhancing the safety and productivity of the world's oil and gas pipelines, or equipment for the production of oil and gas from harsh environments, GE is leading the charge.