RA Manager
7 months ago
Description
:HERE'S WHAT YOU'LL BE DOING:
The RA Manager - APAC enables the business in identifying and implementing efficient, time effective, legal solutions for regulatory topics. The role is accountable to ensure legal compliance while finding solutions that support business growth. The role educates and communicates to all stakeholders the requirements, the process, risks, and progress for all regulatory submissions.HERE'S WHAT YOU'LL BRING TO THE ROLE:
Strategic Role Responsibilities
Maintain current knowledge of CFDA and international regulation, guidance and standards applicable to company products understands best practice and monitors competitors’ movements Monitor and manage APAC and China regulation guidelines and the impact of changing/evolving regulations on country registrations, and license renewals and communicate to management to ensure timelines are met. Oversee new product development and existing timelines in preparation of regulatory documentation for consumables and devices including labeling/artwork and any documentation submission support as it relates to the maintenance of existing licenses. Provide regular updates on APAC and China to regulatory management and business development teams. Provide input and adhere to scheduling and management of Post Market Surveillance (PMS) plans and reports. Review and manage the essential requirements checklist for accuracy and update regularly. Maintains and manages awareness around new and developing legislation, regulatory policy changes and technical guidance related to the consumables and devices and communicates to regulatory management. Review consumable formulas for regulatory compliance regularly. Review Invoices for accuracy and confirm with management. Review and complete change evaluation forms (CEFs) relating to APAC/China Review for accuracy and provide declaration of conformity documents for the APAC/China regions when required. Communicate and work closely with domestic and international regulatory teams for alignment and support. Other duties as assigned by management.Operational Role Responsibilities
Regulatory filings (new/ updates):Sets up efficient internal and external facing processes.Timely compile materials for license renewals, updates, and registrations, leveraging global and local partners, distributors and consultants.Files and then monitors submissions, anticipates issues and creates proactive plan of action/responses. Manages product changes for impact on regulatory filings. Provides Regulatory support for Fujia (Contract Manufacturer) in China when necessary. Engages cross-functional stakeholders pro-actively to communicate regulatory requirements to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions. Communicates APAC/China regulatory requirements and challenges effectively to meet project needs. Communicate any in country testing requirements and units requested as a result. Review marketing material for regulatory compliance Review labeling and labels for compliance with regulatory requirements Provide the regulatory reviews of customer complaints and define the regulatory reportability. Establish and maintain system for tracking changes in documents submitted to agencies or partners in APAC. Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required. Works closely with international and global Quality partners to ensure daily guidance to local Quality employees is given in full alignmentPeople & Leadership Responsibilities
Participates actively in local and U.S. market cross-functional teams Is an active team member of the APAC Regulatory Team Guides, coaches and manages regulatory/quality employees towards achieving functional and organizational goalsFunctional Expertise
Knowledge of medical device and cosmetic regulatory requirements in APAC Strong understanding of design controls To ensure the Registration / ESF Tracker and regulatory tracker is maintained, accurate and updated regularly. Maintain data and regulatory files in the regulatory folders to ensure compliant documents are stored. Requires proficiency with standard software (Word, Excel, PowerPoint, etc.)Soft Skills
Excellent verbal and written communication skills are essential. Ability to manage multiple priorities Requires creative, problem-solving ability and oral and written presentation skills Team oriented, the ability to work in a small team environment is essential; must also be a self-starter with the ability to work independently. Good planning and organization skills are vital. Strong critical thinking and problem-solving skills The ability to meet deadlines and be detailed orientated is necessary.Qualifications
Bachelor’s degree required Specific Area of Study: BS or BA in engineering or scientific fieldExperience
5 to 8 years relevant experience Specific Related Experience: the quality/clinical/regulatory discipline Experience with electromechanical and/or software devices is a plusWhat else can you expect with Hydrafacial?
Every person here is a key player in our success. We are firm believers in making the little things count each day so that the big things will follow. If this sounds like you, come check us out This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
We mean it when we say you’ll LOVE this role.
BeautyHealth is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.
BeautyHealth does not accept unsolicited assistance or resumes/CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV/resume submitted by a search firm to any employee at our company without a valid written search agreement. If we need additional support, we will be sure to reach out directly to one of our preferred providers.Please no phone calls or emails
-
RA Officer
6 months ago
Shanghai, China DSM Full timeRA Officer Location: Shanghai, China On Site To play a crucial role in launching our new Taste business. You'll manage local raw materials introduction and ensure regulatory compliance of Taste products. Shape a successful career with us by driving innovaiton and navigating complex regulations. Make a real impact in a dynamic, growing industry. At...
-
Associate Regulatory Affairs Manager
1 month ago
Shanghai, China Abbott Full timeMajor Responsibilities/Activities: Provide regulatory input to supervisor for decision making on registration filing strategies. Set up product registration timeline and ensure well implement. Prepare and validate registration dossier to ensure fully meet Chinese regulations and guildlines. Track on-going projects and handle technical issues from...
-
Senior Regulatory Affairs Manager
1 month ago
Shanghai, China Abbott Full timeEXPERIENCE: Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post; Solid registration project management skills; Effective problem solving and planning capabilities; Good knowledge of CFDA regulations and guidelines; Good working relationship with regulatory authorities; ...
-
Regulatory Affairs Manager Position
1 month ago
Shanghai, Shanghai, China Abbott Full timeAbout the Role:Collaborate with supervisors to develop and implement effective registration filing strategies.Establish and manage product registration timelines, ensuring timely completion.Prepare and validate registration dossiers to meet Chinese regulations and guidelines.Monitor ongoing projects, addressing technical issues from regulatory authorities to...
-
Shanghai, China NYU Shanghai Full timePosition Summary The Residential Education Program Coordinator, Residence Hall Assistant Director is a full-time university staff position that works with different functional units within the Office of Student Affairs to provide comprehensive residential programs and support students living in residence. The Residence Hall Assistant Director will act...
-
Sales Coordinator
4 weeks ago
Shanghai, China Snaphunt Full timeThe OfferWork alongside & learn from best in class talentA role that offers a breadth of learning opportunitiesOpportunity to make a positive impactThe JobJob Title: B2B Sales Coordinator (Native Mandarin Speaker)Location: Ras Al Khaimah, UAENotice Period: Immediate to 15 daysJob Summary:Our client is looking for a dynamic B2B Sales Coordinator with...
-
SSME MI Senior Regulatory Affairs Officer
4 months ago
Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeJoinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably. Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique...
-
Director Sales RA East
4 months ago
Shanghai, China adidas Full timePurpose & Overall Relevance for the Organization:To ensure profitable market share and net sales growth within regional accountsTo passionately lead the regional accounts organization in identifying, developing and implementing strategies for the profitable growth Key Responsibilities: Responsible for regional accounts all business related KPI, includes...
-
Shanghai, Shanghai, China NYU Shanghai Full timeThe Residential Education Program Coordinator at NYU Shanghai is a dynamic role that combines housing management, student support, and community engagement.About the RoleThis position is responsible for overseeing residential programs, supervising Resident Assistants, and providing holistic support to students living in residence halls. The ideal candidate...
-
Sales Coordinator
4 weeks ago
Shanghai, China NSS ITC Full timeNSS-ITC is a new age technology consulting company head quartered in Dubai with operations in Middle East, India, Europe and the Far East among other global locations. Since 2014, NSS-ITC has been offering consulting services to leading banks and financial institutions to boost growth exponentially by leveraging technology. With our cost-effective offerings...
-
Merchandising Category Manager
4 weeks ago
Shanghai, Shanghai, China Adidas Full timeJob OverviewWe are seeking an experienced Merchandising Category Manager to join our Buying Team. This role will be responsible for executing the inline category, managing merchandising planning, buying, and determining store clusters.Main ResponsibilitiesAnalyze historical data to support team development of buying structure and provide pre-season buying...
-
Assistant Manager, Regulatory Affairs
6 months ago
Shanghai, China L'Oréal Full timeManage APAC regulatory compliance projects on both cosmetic ingredient and finished product to support R&I innovations. Develop robust compliance solutions with cosmetic, chemical and other possible related area regulatory expertise, risk assessment and recommendation, to both upstream and downstream innovation projects led by APAC R&I hubs and coming to...
-
Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeWe are a team of experts in regulatory affairs at Siemens Shanghai Medical Equipment Ltd., dedicated to ensuring our medical devices comply with international and national standards.As a Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet the necessary regulatory requirements. Your responsibilities will include:Key...
-
Lead Tooling Design Engineer
1 month ago
Shanghai, Shanghai, China Rockwell Automation Full timeJob SummaryAs a key member of the tooling engineering team in AP, you will be responsible for planning, costing, developing, and implementing new plastic mold tooling and processes. You will work closely with the fabrication team on replacement tooling projects and report to the Manufacturing Engineering Manager in China.Key Responsibilities:Drive supplier...
-
Regulatory Affairs Manager
4 weeks ago
Shanghai, Shanghai, China Abbott Full timeAbout the Role">We are seeking a highly skilled Regulatory Affairs Manager - Product Registration Specialist to join our team at Abbott. In this critical role, you will be responsible for providing regulatory input to supervisors for decision-making on registration filing strategies.Key Responsibilities">Set up product registration timelines and ensure their...
-
Senior Tooling Engineer
2 months ago
Shanghai, Shanghai, China Rockwell Automation Full timeJob SummaryAs a key member of the tooling engineering team in AP, you will be responsible for planning, costing, developing, and implementing new plastic mold tooling and processes. Under general direction, you will independently solve problems and implement solutions for new plastic injection mold tooling and molding processes. You will work closely with...
-
Manager FRS Retail Operations HQ
7 months ago
Shanghai, China Adidas Full timePurpose & Overall Relevance for the Organization: Play a critical role of operation management through integrating internal resources to drive Must Win stores’ sales growth. Ensure the Must Win stores’ faultless execution landing through process, project and tool design. Collaborate with other teams and meeting to drive must Win stores’ key...
-
Senior Tooling Engineer
6 months ago
Shanghai, China Rockwell Automation Full timeJob Summary Core member of tooling engineering team in AP, and is responsible for planning, costing, developing, and implementing new plastic mold tooling and processes. Under general direction of the functional manager, independently solves problems and implements solutions for new plastic injection mold tooling and molding process. You will Work...
-
Assistant Manager Inline Buying
6 months ago
Shanghai, China Adidas Full timePURPOSE & OVERALL RELEVANCE FOR THE ORGANISATION: This role is responsible for executing the inline category in terms of managing merchandising planning, buying in determining store clusters, article selection, article depth, and timely providing sales analysis, trading/fashion trend recommendation to support the business of FRS/OWN RETAIL/EC channels. ...
-
Shanghai, China Unilever Full timeMain accountabilities and key tasks Closely work with internal colleagues across categories and functional groups and external stakeholders to ensure the successful landing of safety assessment of Unilever products in for China markets. Provide sound solutions to the safety related inquiries/challenges received during product registration/notification...
