Regulatory Affairs Specialist

תיאור התפקיד

Careers that Change Lives
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.
Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives.
A Day in the Life
Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
Performs coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Leads or compiles all materials required in submissions, license renewal and annual registrations for internal and external partners.
Provide customer support to global partners.
To interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.

Must Have:

  • Bachelor’s degree in science with 2+ years of experience in regulatory affairs and/or QA medical device or pharma industry.
  • Excellent English skills (writing, reading and communicating)
  • Product development experience.
  • Ability to comprehend principles of engineering, physiology and medical device use.
  • Familiarity with regulatory submissions and requirements.
  • Previous customer-facing and/or project management experience is a plus.
  • Previous experience working with global team.
  • Comfortable working with international and multi-cultural department and groups.

דרישות התפקיד

Must Have:

  • Bachelor’s degree in science with 2+ years of experience in regulatory affairs and/or QA medical device or pharma industry.
  • Excellent English skills (writing, reading and communicating)
  • Product development experience.
  • Ability to comprehend principles of engineering, physiology and medical device use.
  • Familiarity with regulatory submissions and requirements.
  • Previous customer-facing and/or project management experience is a plus.
  • Previous experience working with global team.
  • Comfortable working with international and multi-cultural department and groups.

Nice to have:

  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Working knowledge Standard, Guidances, and Regulations.
  • Familiarity with regulatory requirements in major markets as US and EU, as well as international markets.
  • Ability to effectively manage multiple projects and priorities.
  • Experience with regulatory submissions.
  • Project management skills.
  • RAPS certification (RAC).

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