RAQA Manager Poland

As an RAQA Manager Poland, you will develop and apply comprehensive knowledge and understanding of the RA / QA / PMS frameworks, legislative requirements, processes and procedures in the Polish and EMEA distribution organization.

What will you do

• You will act as a RAQA Leader, reporting performance, risks and issues to local leadership teams and other Stryker leadership teams where applicable.

• You are passionate about collaborating with others and you enjoy the challenge of unfamiliar tasks.

• You have high standards of integrity and enjoy being respected for being credible.

• you are passionate about promoting the open expression of diverse ideals and opinions.

• You will identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

• You will provide support to EMEA / Country RAQA teams as appropriate.

• You will lead Third Party, Competent Authority or Notified Body audits within the local organization.

• You will lead recruiting, selection, on-boarding and development of talent within the local office to increase performance.

• You will maintain a high level of team engagement and collaboration across the RAQA team in the local office.

• You will monitor team performance and takes action to keep the team on track by providing appropriate coaching and feedback to others.

• You will act as a subject matter expert to the local business.

• You will represent Stryker in local industry association as RAQA subject matter expert in advocacy activities of a more advanced technical and / or tactical or strategic nature.

• You will liaise with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations.

What will you need

• You have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred.

• You have gained minimum 8 years’ experience in QARA function in a Medical Device Company, with 3+ years of supervisory experience.

• You demonstrate knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System and Post Market Surveillance requirements, as well as other international requirements pertaining to the medical device industry.

• You have leadership skills and experience with recruiting, hiring and developing talent.

• You have experience leading meetings with regulatory agencies, internal and external audits and other stakeholders, with minimal support.

• You are fluent in English and Polish.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com