Senior Regulatory Specialist

Location Best
Discipline: Medical Device
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email: s.ozbeden@panda-int.com
Job ref: 14387
Published: 23 days ago

For a leading Medical Device client I'm looking for a Senior Regulatory Specialist with minimum of 5 years of experience in the medical device industry and technical environment. 

RESPONSIBILITIES

  • Work according the business applicable processes and as ambassador of the company values.
  • Train regulatory resources in their development.
  • Exercise supervision in terms of schedules, methods and staffing for projects leading
  • Establishes operational objectives and work plans, and delegates assignments to project team members.
  • Keeps abreast of current regulatory procedures and changes
  • Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
  • (support)Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance.
  • Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape , regulatory/ legislative initiatives, and product marketing strategy for their responsible products within IGT-S Fixed portfolio
  • Responsible for product registrations/approvals in her/his field.
  • Leads regulatory resources as part of projects (s)he works in.
     
PROFILE
  • Minimal of 5 years of experience in the medical device industry and technical environment with at least 3 years in an Imaging Diagnostic medical device company( FDA Class II equivalent – Class III a plus)
  • Must have experience with successful preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide
  • Strong background in Design Controls
  • Excellent working knowledge of Standards like IEC62304/82304/60601
  • Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
  • Experience in supporting international registrations and clinical investigations(as a plus)
  • Bachelor’s degree in a technical/quality/law/pharma discipline
  • RAPS certified(as a plus)

PRACTICALITIES
  • Duration: 6 months - high chance of extension
  • Start date: ASAP
  • Location: Best

Interested?
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on     +31 (0)20 20 44 502
https://panda-int.staffingreferrals.com/meet/sozbeden1