Risk Manager i Stockholms län

Publicerad: 2017-07-12
Stockholms län
Life Science
Produktion & processteknik
Jenny Davidsson
070-544 82 38
Do you want to develop in a growing company that continuously strengthens its position through innovative products? Then this is the right position for you!

SHL Group AB offers you a job in a dynamic environment where we develop and manufacture products that improve human health. As a co-worker, you take a big responsibility and join a Swedish company in a global organization. Our customer relationships are long-term, and we want a long-term value-creating relationship for you as employees. Your personal development at work is of great importance to us!

The role:

As our Risk Manager, you will lead activities/projects and contribute to the development, integration, and advancement of Risk Management across SHL. You will lead the planning, management and implementation of internal projects and customer projects in areas of product commercialization and launch, operations and development. You will also be responsible for generating and maintaining the risk management files for several products/projects and for ensuring compliance to international standards for maintaining a medical device risk management program throughout the product lifecycle. All activities contributes to delivering safe and effective products. You will be working independently as well as in global development project teams, and establish direct communication with our requirement originators, i.e. customers like large pharmaceutical manufacturers.

Travels to customers and to our site in Taiwan are included in the position.

Responsibilities also includes:

• Update the Risk Management Files based on product and process changes as well as post-production data such as CAPA and complaints.

• Serve as the company's representative in all aspects of Risk Management for regulatory inspections, Notified Body audits, Customer audits and internal audits.

• Coordinate activities and collaboration with Quality Assurance and Engineering leaders and other key business partners regarding design and implementation of the company-wide Product Risk Management process for pre- and post-market aspects

Who you are:
We want all our employees to be development-oriented, positive, open and ambitious team players.

In addition, we believe you have the following experience and qualifications:

• Bachelor’s degree in Engineering, Science, or similar technical degree.

• Extensive knowledge and experience in risk management assessment for medical devices.

• Knowledge of International Organization for Standardization (ISO) standards, specifically ISO 13485, ISO 14971.

• Understanding of Good Documentation Practice (GDP).

• Experience in creating, reviewing, and approving quality systems documentation.

• Must have excellent written and oral communication skills, English is a requirement.

• Strong leadership, influencing, negotiation skills.

• Experience with working with pharmaceutical companies is a plus (especially within parenterals).

• Ability to work in a Global Environment

Information & Application:
In this recruitment SHL is collaborating with Dfind Science & Engineering. Please contact recruitment consultant Jenny Davidsson, +46-70-5448238, for questions. Please submit your application in English at www.dfind.se. The last day to apply is 12th of August 2017.

SHL Medical is a leader in the design, development, and manufacturing of advanced drug delivery devices such as auto injectors, pen injectors, and inhaler systems. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices to effectively deliver their drugs. These self-administered devices can empower patients by allowing them to take their medications in the comfort of their homes or under the supervision of their healthcare providers.