Senior Regulatory Affairs Specialist

Regulatory Affairs, Medical Devices, Stockholm, Johnson & Johnson
Hays is recruiting a Senior Regulatory Affairs Specialist to our client Johnson & Johnson. The position is permanent and based in Stockholm.

About the Johnson & Johnson Medical Devices Companies
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity. The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

Introduction and Overview
The combination of your global policy view and local approach to markets and customers will help us build trust and influence customers, industry peers and regulatory partners. You will partner with regional regulatory strategy and innovation teams on pre-market approvals, connect with manufacturing teams on process and labeling, and work with local sales and marketing teams on product positioning and marketing claims. You will flourish in a rich culture and changing healthcare environment based on exchange of expertise and your analytical skills will advise our companies on legal requirements and shape the regulatory environment. You will be involved in all stages of the product lifecycle and contribute to innovative ideas, product improvements, and service models that advance the health and well-being of patients and consumers to protect our customers and ensure that our businesses are compliant in Nordic countries.

Senior Regulatory Affairs Specialist
As Regulatory Affairs Specialist in the Nordic Countries (Denmark, Finland, Iceland, Norway, Sweden) you ensure regulatory compliance of products for their distribution to local market and follow-up their life cycle.

Objectives of the Position
  • Manage regulatory requirements and documentations regarding placing on the market of products (medical devices, drugs, human tissues, veterinary products, …).
  • Identify rapidly regulatory issues concerning products, report them to management and manufacturer, investigate and suggest solutions to resolve them.
  • Support compliance with local applicable environmental regulations (WEE/Batteries/Packaging/RoHS …).
  • Oversee local company licenses and registration of products (medical devices, drugs, veterinary products, human tissue products, …).
  • Review and validate promotional materials.
  • Review and validate labelling of products in local language.
  • Provide regulatory support to marketing, sales representatives, customers, customer service.
  • Perform regulatory training and assessments for marketing, sales representative and all other Johnson & Johnson Medical Devices’ relevant employees.
  • Review and update processes and procedures linked to all relevant regulatory activities.
  • Represent Johnson & Johnson Medical Devices in various internal and external forums as trade associations, meetings with local health authorities.
  • Liaison with local competent authorities.
  • Work collaboratively with the regional policy to ensure consistency of policy shaping activities and all activities linked to regulatory intelligence.
  • Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures.

Qualifications required
  • University degree required. Advanced degrees and education in pharmacy, medicine, engineering or science.
  • First successful experience in similar position in an international company (regulatory and/or quality).
  • Languages: Fluent in English and at least one of the Nordics languages (Danish, Swedish, Norwegian).
  • This position is based in one of the Nordic countries.

What you will need to succeed
  • Profound knowledge of regulatory requirements in medical devices and/or drugs.
  • Ability to persuasive communicate and influence regulators and other key stakeholders.
  • Highly skilled in establishing partnerships and collaboration with business partners, manufacturer and regional regulatory affairs, as well as other stakeholders.
  • Strong results-orientation, ability to execute multiple tasks effectively and sense of urgency.
  • Solid capacity to analyze, interpret and synthesize on regulation and guidelines.
  • Able to work independently with strong capability of self-awareness and adaptability.

What you need to do now
In this recruitment Johnson & Johnson is working with Hays Life Sciences. If you're interested in this role, then apply with an up-to-date copy of your CV and personal letter in one document. For inquiries regarding the position or process please contact the responsible recruitment consultant Helena Marteus or Isolde Andersson. Selection of candidates will be carried out continously, so be sure to send in your application as soon as possible.


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Tala med en konsult

Tala med Isolde Andersson, specialistkonsulten som hanterar denna position, i 114 35

Sturegallerian, Stureplan 4C, 114 35, Sweden, Stockholm

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