Senior Regulatory Affairs Specialist

1 day ago

Yoqneam Illit North Israel Medtronic Full time ₪80,000 - ₪120,000 per year

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the LifeIf you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we'd love to hear from you. Join us as a Senior Regulatory Affairs Specialist.
Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries.
The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally.

Responsibilities may include the following and other duties may be assigned:

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
  • Leads or compiles all materials required in submissions, license renewal and annual registrations
  • Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
  • Write, update and maintain technical documentation
  • Review promotional material for accuracy and compliance 
  • May direct interaction with regulatory agencies on defined matters
  • Recommends strategies for earliest possible approvals of regulatory applications.

Required Knowledge and Experience:

  • Bachelor's degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
  • Experience in the medical device industry
  • Excellent attention to details, proactive approach and ability to work independently
  • Ability to work well under pressure and multitask
  • Ability to work flexible hours supporting US sites and production lines
  • Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation) 
  • High learning agility and ability to work under pressure
  • Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here  
 

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