Regulatory Affairs Specialist

vor 12 Stunden

Lausanne, Waadt, Schweiz Medtronic Vollzeit

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 LifeMedtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established, productive individual contributor who works independently on moderately complex projects with general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You may also participate in cross-functional activities, requiring awareness of wider organizational issues even though the challenges you face are generally not highly complex.

You will recommend improvements to systems and processes to enhance effectiveness and regularly communicate with internal stakeholders to share updates, gather input, and support decision-making. While your external interactions are limited and straightforward, you may guide entry-level professionals or support staff, eventually offering direction and assistance when needed.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

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

  • Direct or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Lead and compile all materials required in submissions, license renewal and annual registrations.
  • Recommend changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitor and improve tracking as well as control systems.
  • Keep abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommend strategies for earliest possible approvals of clinical trials applications.

Required knowledge and experience

  • Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
  • 2-5 years of medical device regulatory experience (depending on level) tied to Swissmedic submissions and processes, with strong knowledge of Swiss Medical Device Ordinance (MedDO/MepV, understanding of EU MDR compliance (due to Mutual Recognition Agreement), as well as experience with conformity assessment procedures under Swiss law
  • Proficiency in German (often mandatory as primary business language), English and French
  • Experience in ISO 13485 Quality Management Systems, risk management experience (ISO 14971, EN 14971), with strong background in understanding of Swiss device classification system, clinical evaluation and post-market surveillance, as well as strong knowledge of Swiss Authorized Representative requirements
  • Experience with Swissmedic registration processes, technical documentation preparation, interaction with Notified Body for EU conformity assessment, as well as import/distribution licensing procedures, Field Safety Corrective Actions (FSCA) support, while also possessing expertise in hosting or supporting regulatory audits

#LI-Remote

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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