Senior RA specialist
1개월전에
The purpose of this role is to provide regulatory expertise to ensures rapid and timely approvals for respective product lines by plans, manage preparation and documentation of all product registrations including his/her direct report’s. In addition, this role requires to interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
Key Responsibilities
Prioritize and develop strategies on product registration including KGMP certification for his/her respective product lines.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Supervising his/her direct reports including administration of performance management and individual development plans.
Provides input on regulatory-related issues associated with compliance and achieving the business plan.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes and share the changes with internal stakeholders in a timely manner.
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
Participate in global projects with regard to
-
Senior RA specialist
4주전에
South Korea SUCCESSKOREA 풀타임채용제목 Senior RA specialist 회사소개 미국계 글로벌 의료기기 회사 업무내용/자격요건 [담당직무] The purpose of this role is to provide regulatory expertise to ensures rapid and timely approvals for respective product lines by plans, manage preparation and documentation of all product registrations including his/her direct...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist, RA/QA (지원마감) 회사소개 외국계 의료기기 회사 업무내용/자격요건 담당직무 -Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission. -Manage & control the regulatory requirements and documents with well-organized filing/recording &...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist, RA/QA (지원마감) 회사소개 외국계 의료기기 회사 업무내용/자격요건 담당직무 -Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission....
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist, RA 과차장급 (지원마감) 회사소개 외국계 의료기기 회사 업무내용/자격요건 담당직무 -Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission....
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist, RA 과차장급 (지원마감) 회사소개 외국계 의료기기 회사 업무내용/자격요건 담당직무 -Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission. -Manage & control the regulatory requirements and documents with well-organized...
-
RA Specialist, ARK
4주전에
South Korea Arthrex 풀타임Description Main Objective: This role supports the RA Manager to ensure Arthrex Korea meets RA requirements and processes quality control in accordance with regulatory and corporate standards. This role contributes to Arthrex Korea's business results by providing accurate and proper RA information and services to business team. Essential Duties and...
-
RA Specialist, ARK
6 일전에
South Korea Arthrex 풀타임Description Main Objective: This role supports the RA Manager to ensure Arthrex Korea meets RA requirements and processes quality control in accordance with regulatory and corporate standards. This role contributes to Arthrex Korea’s business results by providing accurate and proper RA information and services to business team. Essential...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist, RA/QA 차장급 (지원마감) 회사소개 외국계 의료기기 회사 업무내용/자격요건 담당직무 -Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission....
-
South Korea SUCCESSKOREA 풀타임채용제목 Country approval specialist(RA) (지원마감) 회사소개 Global CRO 업무내용/자격요건 담당직무 - Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with...
-
South Korea SUCCESSKOREA 풀타임채용제목 Country approval specialist(RA) (지원마감) 회사소개 Global CRO 업무내용/자격요건 담당직무...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist, RA/QA 차장급 (지원마감) 회사소개 외국계 의료기기 회사 업무내용/자격요건 담당직무 -Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission. -Manage & control the regulatory requirements and documents with well-organized...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs_Sr. RAC Specialist (지원마감) 회사소개 외국계 의료기기회사 업무내용/자격요건 담당직무 1. Initiate, track and facilitate new product registrations in Korea and achieve on-time approvals 2. Review and approve the Korean labeling and promotional materials...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs_Sr. RAC Specialist (지원마감) 회사소개 외국계 의료기기회사 업무내용/자격요건 담당직무 1. Initiate, track and facilitate new product registrations in Korea and achieve on-time approvals 2. Review and approve the Korean labeling and promotional materials 3. Support WW export business for regulatory...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist 사원급 (지원마감) 회사소개 미국계 의료기기업체 업무내용/자격요건 담당직무 - Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission. - Manage & control the regulatory requirements and documents with well-organized filing/recording &...
-
South Korea SUCCESSKOREA 풀타임채용제목 Regulatory Affairs Specialist 사원급 (지원마감) 회사소개 미국계 의료기기업체 업무내용/자격요건 담당직무 - Responsible for Korea MFDS submissions and QMS(Quality Management System) with the reimbursement submission....
-
South Korea Media 풀타임Responsibilities will include: As a consultative partner, the Senior Digital Media Specialist will advise Media.Monk's clients on industry trends and ways to harness different technology solutions to drive long-term value. Successful candidates for this opportunity will demonstrate strategic thought and client management skills that go beyond platform...
-
South Korea Media.Monks 풀타임Responsibilities will include: As a consultative partner, the Senior Digital Media Specialist will advise Media.Monk’s clients on industry trends and ways to harness different technology solutions to drive long-term value. Successful candidates for this opportunity will demonstrate strategic thought and client management skills that go beyond platform...
-
South Korea OTB 풀타임[OTB Korea] Store Planning Senior Specialist - Diesel, Maison Margiela, Jil Sander, Marni About OTB Group OTB is an international fashion group comprising the iconic, unconventional brands Diesel, Jil Sander, Maison Margiela, Marni and Viktor&Rolf. It also controls the Staff International and Brave Kid companies and holds a stake in American brand...
-
Senior Specialist
18시간전에
South Korea MatchaTalent 풀타임This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabia's oil-rich region, this multinational corporation has solidified its position as a global leader in the petrochemical sector. With a diverse product portfolio ranging from chemicals and intermediates to polymers,...
-
South Korea OTB 풀타임[OTB Korea] Retail Specialist - Jil Sander, Diesel About OTB Group OTB is an international fashion group comprising the iconic, unconventional brands Diesel, Jil Sander, Maison Margiela, Marni and Viktor&Rolf. It also controls the Staff International and Brave Kid companies and holds a stake in American brand Amiri. OTB – short for Only The...
