| Job Description: |
Role Summary/Purpose The Regulatory Affairs Manager provides subject matter expertise to ensure GE Healthcare (GEHC) establishes & implements best practices in the areas of advertising & promotional material. Essential Responsibilities · Lead regulatory activities related to regulatory review and policies of advertising and promotional material and related processes.
· Implement related regulatory guidance for sales/marketing staff
· Provide regulatory support for cross-functional regulatory/marketing/legal teams and working groups.
· Review advertising and promotional materials to ensure compliance with applicable laws and regulations.
· Support auditing of advertising and promotional materials to ensure compliance, partner with business and global counterparts to ensure compliance of emerging media (internet, online tools, etc),
· Support supplier quality in ensuring compliance with regulatory requirements, including procedure & work instruction development
· Analyze and communicate regulatory trends and their implications for GE Healthcare; develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements
· Lead and support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation.
· Liaise with external regulatory bodies to guide input into regulatory strategies.
· Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to assist in or develop & implement programs and processes for regulatory compliance.
· Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility.
· Collect, summarize & analyze performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
· Educate, train, & advise company professionals to ensure compliance with RA requirements. Qualifications/Requirements 1. Bachelor’s Degree & minimum of 7 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 11 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.
2. Demonstrated experience operating in a highly regulated environment; proven application of analytical skills in a regulatory environment
3. Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.
4. Demonstrated project management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals
5. Demonstrated ability to lead cross-functional, cross-business teams.
6. Ability to influence and make recommendations at multiple levels of the company
7. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.
8. Experience using spreadsheet and presentation software
9. Must be willing to travel up to 25% of time. Desired Characteristics 1. Advanced degree in scientific, technology or legal disciplines.
2. Regulatory experience in ad/promo
3. Regulatory Affairs Certification (RAPS).
4. Knowledge of Quality Management Systems (QMS).
5. Experience working across cultures/countries/sites.
6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
7. Strong problem solving and negotiation skills.
8. Demonstrated ability to work well independently & in a team setting.
9. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively.
10. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
11. Written and spoken second language in Mandarin.
|
