Regulatory Affairs Leader

Job description / Role

Role Summary:

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:
- 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
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
- Effectively support implementation & management of current regulatory requirements within area of responsibility
- Ensure assigned regulatory submissions are accurate, complete and timely

Requirements

Qualifications/Requirements:

- Bachelor's Degree (or internationally recognized equivalent) & minimum of 6 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 8 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 or equivalent knowledge or experience
- Ability to prioritize, plan & evaluate deliverables to established strategic goals
- Proven application of analytical skills in a regulatory environment
- Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
- Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research
- Strong problem solving and negotiation skills
- Ability to work well independently & in a team setting
- Prior experience using spreadsheet and presentation software

Desired Characteristics:

- 7-8 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


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 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.

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.