Associate Director Regulatory Affairs
1 month ago
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. The Opportunity As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products in APAC. What You’ll Work On Identify need for new regulatory policies, processes and SOPs in APAC and approve them. Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle. Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Develop APAC regulatory strategies and update based upon regulatory changes. Conduct regulatory due diligence for potential and new acquisitions and advise management. Utilize technical regulatory skills to propose strategies on complex issues. Integrate regulatory considerations into the APAC product entry and exit strategy. Recruit, develop and manage regulatory professionals. Provide guidance for resource and development planning Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges. Review and approve labeling to ensure compliance. Represent regulatory affairs in product recall and recall communication process in APAC. Provide strategic input and technical guidance on regulatory authority queries. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Create project plans and timelines. Lead cross functional groups in the development of relevant data to complete a regulatory submission. Develop and communicate a vision for the organizational unit assigned. Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Negotiate with regulatory authorities during the development and review process to ensure submission approval. Write and edit technical documents. Ensure compliance with product post-marketing approval requirements Review and approve advertising and promotional items to ensure regulatory compliance. Required Qualifications Bachelor's Degree, preferably in science, math or medical fields Minimum 5 years’ experience in a regulated industry. Preferred Qualifications Masters in technical area or MBA Minimum 5+ years’ experience in regulatory affairs. Experience working with Medical Devices, software, or combination products. Experience working in supporting APAC region. Ability to communicate both orally and in writing in Chinese, Japanese and/or other Asian language. RAPS Certification. #J-18808-Ljbffr
-
Associate, Regulatory Affairs
1 week ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeRoles & ResponsibilitiesAbout APACMedFounded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully...
-
Regulatory Affairs Director, APAC
3 weeks ago
SG, SINGAPORE, VIRTUAL Solventum Full timeRole Overview:As the Regulatory Affairs Director for Solventum, you will lead the APAC Regulatory Affairs team, playing a critical strategic role in ensuring compliance and driving business success. Your expertise will be essential in developing and executing regulatory strategies to achieve product approvals faster than competitors.Key...
-
Regulatory Affairs Director
3 weeks ago
Singapore ABIORES PTE. LTD. Full timeRoles & ResponsibilitiesJob Description:- Develop and implement regulatory strategies to secure product approvals more quickly than competitors.- Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment.- Provide expert advice on regulatory strategy, Health Authority engagement, and submission...
-
Regulatory Affairs Associate
3 weeks ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & Responsibilities Regulatory Affairs Associate with global Medical Device MNC Opportunity to work on local and regional submissionsPartnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).Reporting to the RA/QA Director, we are looking for...
-
Regulatory Affairs Director
3 weeks ago
Singapore ABIORES PTE. LTD. Full timeJob Title: Senior Regulatory StrategistRegulatory Affairs at ABIORES PTE. LTD.At ABIORES PTE. LTD., we are seeking an experienced Senior Regulatory Strategist to lead our regulatory affairs efforts. As a key member of our team, you will develop and implement regulatory strategies to secure product approvals quickly and efficiently.Key Responsibilities:•...
-
Public Affairs Director
5 days ago
Singapore foodpanda Full timeJob Title: Public Affairs DirectorJob Summary:We are seeking a seasoned Public Affairs Director to drive foodpanda's public affairs objectives in Singapore. The successful candidate will lead our public policy and advocacy strategy, collaborating with business verticals, industry associations, and stakeholders to achieve our goals.Key Responsibilities:Lead...
-
Regulatory affairs director, apac
2 weeks ago
Singapore Solventum Full timeThank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3 M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3 M branding. Please bear...
-
Senior Regulatory Affairs Manager
2 days ago
Singapore SL-Human Resource Consultancy Pte Ltd Full timeSL-Human Resource Consultancy Pte Ltd is seeking a highly experienced Regulatory Affairs Director to oversee and manage all regulatory activities in Singapore.Estimated Salary: $120,000 - $180,000 per yearThis role will involve ensuring compliance with local and international regulations, developing regulatory strategies to support business objectives, and...
-
Regulatory Affairs Director, APAC
5 days ago
SG, SINGAPORE, VIRTUAL Solventum Full timeJob DescriptionSolventum is a pioneering company that enables better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the...
-
Senior Regulatory Affairs Leader
4 days ago
Singapore Mondelēz International Full timeAbout Mondelēz InternationalMondelēz International is a global snacking powerhouse with a diverse portfolio of beloved brands. Headquartered in Singapore, our Asia, Middle East, and Africa (AMEA) region comprises six business units, employs over 21,000 people, and operates in more than 27 countries.Job SummaryWe are seeking an experienced Senior Manager to...
-
Regulatory Affairs Coordinator
3 weeks ago
Singapore EPIC MEDICAL PTE. LTD. Full timeRegulatory Affairs InternshipEPIC MEDICAL PTE. LTD. is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as a Regulatory Affairs Intern.This exciting opportunity will provide the chance to gain hands-on experience in the preparation, submission, and monitoring of regulatory documents for healthcare/medical...
-
Regulatory Affairs Executive
2 months ago
Singapore ITS SCIENCE & MEDICAL PTE LTD Full timeRoles & ResponsibilitiesJOB SUMMARYThe Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all required national and international regulations and standards. This position involves working closely with various external regulatory authorities and stakeholders, and internal departments to provide expertise...
-
Regulatory Affairs Intern
3 weeks ago
Singapore EPIC MEDICAL PTE. LTD. Full timeRoles & ResponsibilitiesJob Description: Regulatory Affairs InternLocation: SingaporeDepartment: Regulatory AffairsDuration: 6 monthsPosition Overview:We are seeking a highly motivated and detail-oriented intern to join our Regulatory Affairs team. As a Regulatory Affairs Intern, you will have the opportunity to gain hands-on experience in the preparation,...
-
Regulatory Affairs Director for Medical Devices
4 weeks ago
Singapore Careers@Gov Full timeJob SummaryCareers@Gov is seeking a highly experienced Regulatory Affairs Director for Medical Devices to lead the development and implementation of regulatory strategies for medical devices. The successful candidate will be responsible for ensuring that medical devices meet appropriate standards of safety, quality, and efficacy to safeguard national health...
-
Lead Regulatory Affairs Strategist, APAC
7 days ago
SG, SINGAPORE, VIRTUAL Solventum Full timeOverviewSolventum is a pioneering healthcare company that creates innovative solutions to improve lives. As a leading manufacturer of medical devices, we partner with the brightest minds in healthcare to deliver breakthrough products that change patients' lives for the better.Job DescriptionWe are seeking an experienced Regulatory Affairs Director to lead...
-
Regulatory affairs coordinator
2 weeks ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Location: Singapore, Singapore Time Type: Full time Posted on: 5 Days Ago Job Requisition ID: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of...
-
Regulatory affairs coordinator
2 weeks ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Apply to locations: Singapore, Singapore Time type: Full time Posted on: 6 Days Ago Job requisition id: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...
-
Regulatory Affairs Director for Medical Devices
4 weeks ago
Singapore Careers@Gov Full timeJob SummaryAs the Director of Medical Device Governance, you will lead the development and implementation of strategies to ensure the safety, quality, and efficacy of medical devices in the market. Your expertise in regulatory affairs and leadership skills will be crucial in building a credible and innovative regulator of medical devices.Key...
-
Regulatory Affairs Specialist
3 weeks ago
Singapore BEATHCHAPMAN (PTE. LTD.) Full timeWe are seeking an IVD product registration expert for a company specializing in the IVD space. This position will primarily focus on registering products in SEA and globally.The Regulatory Affairs Specialist will be responsible for:Reviewing current product approvals and registrations to assess the state of the SEA business.Working with the commercial team...
-
Regulatory Affairs Specialist
3 weeks ago
Singapore IQVIA Full timeKey Responsibilities:Deliver regulatory projects on time and with a proactive approach, coordinating with in-country regulatory team leads.Core Competencies:Identify and interpret regulations, guidelines, and other pertinent information issued by regulatory agencies.Review scientific data, publications, and related papers to ensure compliance with...