채용정보

W Medical Strategy Group

[KOTRA] Regulatory Specialist, Medical Device Regulatory Associate 상시채용

조회 138 | 스크랩 1 | 등록일 21.09.09

담당업무

  • 기타영업
  • 바이오·제약·식품

지원내용

  • 온라인 접수
  • 4년제 대학 졸업

근무 상세 내용

  • 고용형태: 정규직
  • 급여: 면접 후 결정
  • 지역: 뉴저지
  • 근무요일: 주 5일(월, 화, 수, 목, 금)
  • 근무시간: 09:00 am ~ 06:00 pm
  • 취업비자 스폰서 가능

[W Medical Strategy Group]

Established in 2014, W Medical Strategy Group is a healthcare consulting firm that uses deep industry expertise to help healthcare companies achieve optimal business results.

 

1. Regulatory Specialist

WR Regulatory Services LLC, a US Regulatory Affairs consulting firm and a subsidiary of W Medical Strategy Group, is seeking to hire a full-time US Regulatory Specialist and Consultant with:

  • Thorough knowledge and expertise in FDA regulatory affairs for pharmaceutical, biologics, and combination products including regulations and guidances related to CMC, nonclinical, clinical P1 through P3, Pharmacovigilance, and preparing/conducting FDA milestone meetings.
  • Practical hands-on experience in preparing, submitting and maintaining FDA Orphan Drug Designations, INDs, BLAs, NDAs, ANDAs, DMFs, Suitability/Citizen Petitions, GDUFA Self-ID, Establishment Registration, and Drug Listing
  • Exceptional communication skills in written, verbal, and presentation formats in communications with 3rd parties and FDA representatives

The successful candidate will assist WR Regulatory Services clients in managing their US FDA development projects.

 

Featured Responsibilities:

  • Willingness to lead and run interactions with FDA on behalf of our clients, including providing pre-meeting coaching and preparation, serving as Sponsor Agent/ Representative to the FDA
  • Prepare for FDA meetings including: (1) meeting document preparation and submission, (2) working with clients to organize meetings, (3) manage and attend FDA meetings
  • Prepare and submit INDs, BLAs, NDAs, ANDAs, DMFs, Orphan Drug Applications, and all documents/submissions critical to product life cycle
  • Communicate with FDA relating to regulatory matters on behalf of clients Communicate and interpret FDA regulations, policies, and guidances for WR Regulatory Services and our clients
  • Provide early input and participate in project scope definition and proposal/statement of work authoring
  • Prepare and manage schedules, budgets, and SOPs

Qualifications:

Required

  • US citizenship or US Permanent Resident status 
  • A valid passport for international travel
  • Bachelor’s degree in a science field with at least 5 years of FDA Regulatory Affairs experience in a biotech and/or pharmaceutical industry
  • Substantial experience in Orphan Drug, IND, BLA, NDA, ANDA, DMF, and FDA meeting preparation and submissions.
  • Competency working in CTD and eCTD format
  • Comprehensive knowledge of, and ability to interpret, FDA regulations, policies and guidances
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate and independently manage multiple and diverse projects simultaneously
  • Ability to effectively interact directly, and in a team environment, with national and international clients, Company staff, and 3 rd party contractors
  • Regulatory Affairs Professionals Society Certification (RAC) designation preferred
  • Proficiency in Microsoft Office programs

Preferred

  • Advanced Education and/or Certifications
  • Prior Consulting experience
  • Experience with multiple product types (small molecules, biologics, etc.)
  • Secondary language skills (Spanish, Italian, French, German, Mandarin, other) preferred
  • Korean language fluency
  • Willingness to speak/train at workshops and seminars

Annual Salary: $70,000~$135,000 (Gross/depending on experience)

 

2. Medical Device Regulatory Associate 

WR Regulatory Services LLC, a subsidiary of W Medical Strategy Group, is a US Regulatory Affairs consulting firm seeking to hire a full-time Consultant and Medical Device Regulatory Specialist with:

  • Knowledge and expertise in the following areas: FDA regulations and guidances for Medical Devices
  • Practical hands-on experience in preparing 510k submissions conducting FDA Pre-Submission meetings
  • Good knowledge of strategy development and implementation techniques for Medical Device registrations.
  • Strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

The successful candidate will assist WR Regulatory Services clients in managing their US FDA Medical Device development projects.

Featured Responsibilities

  • Identify the FDA regulatory pathway for client medical devices
  • Prepare classification rationales and draft testing plans
  • Prepare and submit pre-submission meeting requests with FDA
  • Draft regulatory strategies in line with client business objectives and regulations
  • Draft 510k submissions and RFDs
  • Serve as liaison with the FDA Center for Devices
  • Assist in writings regulatory and technical documentation and design dossiers in support of FDA device submissions

Qualifications
 

Required

  • Experience writing or project managing 510ks
  • Knowledge of Quality Management Systems implementation to ISO 13485:2016
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Worked in a client-focused organization as a consultant in the past
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices
  • Fluent in English

Preferred

  • Advanced Education and/or Certifications
  • Prior Consulting experience
  • Experience with RFDs, IDEs, PMAs, De Novo and IVDs.
  • Knowledge of medical device regulations related to major health authorities of EU, Canada or other health authorities
  • RAC medical device regulation certification
  • Secondary language skills (Spanish, Italian, French, German, Mandarin, other)
  • Korean language fluency

Annual Salary: $55,000~$85,000 (Gross/depending on experience)

 

 

[Working Conditions]

- Full time position

- Work Hours : Mon.- Fri at 9am to 6pm

- H1-B and J1 visa sponsorship is available for ideal candidates

 

WR Regulatory Services office is located in Englewood Cliffs, New Jersey. The candidate is expected to work at this location, although partial remote work will be considered.

 

*Send your resume and cover letter to Jisoo.yoon@wmedical.org and CC to Resume.KMoveNY@gmail.com 

*Make the title of Email: [Company Name]_[Position]_[Your Name]

근무 상세 내용

  • 고용형태: 정규직
  • 지역: 뉴저지
  • 근무요일: 주 5일(월, 화, 수, 목, 금)
  • 근무시간: 09:00 am ~ 06:00 pm
  • 급여: 면접 후 결정
  • 취업비자 스폰서 가능

접수방법 및 기간

  • 접수방법: 온라인 접수
  • 접수기간: 상시채용

W Medical Strategy Group

기업정보

  • 기업명 W Medical Strategy Group
  • 대표자 DoHyun Cho
  • 설립일 -
  • 인사담당자 -
  • 업종 Consulting / Distribution / Marketing
  • 사원수 -
  • 위치 440 Sylvan Ave, Englewood Cliffs, 07632 뉴저지, 미국
  • 담당이메일 resume.kmoveny@gmail.com
  • 전화번호 1 - 201-402-1400

접수기간

마감일: 상시채용

접수방법

지원방법 : 온라인 접수 즉시지원