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Danaher Corporation Regulatory Affairs Specialist / Sr. Specialist (m/f/d) in Heerbrugg, Switzerland

For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.

Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.

Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

We currently offer the following position in our office in Heerbrugg, Switzerland which will be hybrid with flexible office and home-office time. You will join an exciting and diverse Team of Regulatory, Quality and Clinical experts.

The Regulatory Affairs Specialist / Sr. Specialist (m/f/d) is responsible for supporting the cross-functional teams in establishing and complying with Regulatory requirements for the assigned projects, medical devices (products) and geographical areas.

The role is also responsible for monitoring the evolving Regulatory world and respective changes, while keeping general maintenance of compliance of Leica’s medical devices throughout their lifecycle.

In this role you work closely with Product Management, Marketing, R&D, Industrial Engineering, Scientific Affairs, Product Compliance and Manufacturing to define and execute regulatory strategies and deliverables that ensure timely regulatory clearance of newly developed Medical Devices as well as maintenance of registrations of medical devices that are already on the market.

YOUR RESPONSIBILITIES

Regulatory Projects

  • Supports and/or drives Regulatory initiatives.

  • Provides regulatory support for business initiatives on assigned specific projects

  • Evaluates the impact of new external requirements and works closely with relevant stakeholders to ensure compliance

  • Supports implementation of IT tools used in Regulatory Activities

Regulatory Affairs

  • Ensures regulations and standards monitoring

  • Defines regulatory strategy and requirements in support to new product introduction and lifecycle management projects

  • Creates and maintains Technical Documentation (EU MDR), US FDA submissions (e.g. 510(k))

  • Assesses impact of changes on product registrations world-wide

  • Supports creation and review of needed deliverables in accordance with the medical device development and change management processes

  • Maintains and supports international product registrations

  • Oversees and handles all needed regulatory activities in assigned region (EMEA)

  • Supports RAQA team with relevant regulatory deliverables in support of vigilance activities

  • Supports RAQA team in continuous improvement projects

OUR EXPECTATIONS

  • Degree from a technical college or university

  • Minimum 3 years of RA and/or QA experience in the medical device industry

  • Experience in leading continuous improvement projects in a matrix organization (ASQ, six sigma, lean certification would be a plus)

  • Experience in working with ISO 13485, MDD, MDR and FDA 21 CFR

  • English (mandatory), any other languages are considered a plus

WHAT WE OFFER

  • Attractive compensation package

  • Employees have the option to work from home up to 2 days/week

  • We offer flexible working time models - for us, New Work is more than just home office

  • We have no room for prejudices and stereotypes. We promote equal opportunities, diversity and inclusion. #Charterof Diversity

  • We offer a balance between support and autonomy to achieve your own goals in an international environment

  • With us you get the chance to successfully contribute your own ideas

GET MORE INSIGHT

Learn more about what we do and who we are by watching our company video “We Are Leica”: https://www.youtube.com/watch?v=1zHmalqMXN4

At Leica Microsystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Microsystems can provide.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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