Job ID: 11721

Manager (m/w/d) Regulatory Affairs

Stellenart.

Festanstellung

Ihre Aufgaben.

In the role as Manager (m/w/d) Regulatory Affairs you are leading the RA department of BRAHMS GmbH (Hennigsdorf). You are setting the direction for achieving added value and securing/maintaining compliance to international regulations by implementing and executing regulatory processes throughout all different departments according to international standards and regulations (e.g. ISO 13485, MDSAP, 21 CFR 820).

What will you do?

  • Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of products‘ registration.
  • Establish and lead all aspects of regulatory strategy including successfully handling global regulatory submission projects, such that they integrate with the overall objectives of the program they support.
  • Ensure that Regulatory Affairs (RA) teams globally are accountable for delivering on agreed strategies and tactics.
  • Participate in product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
  • Lead resources to ensure each project/core teams have appropriate regulatory support, mentorship, and resources to develop regulatory strategies and timelines.
  • Responsible for the planning and implementation of all regulatory activities in the product life cycle in coordination with the Director RA/QA
  • Implement, follow and continuously improve various RA processes according to international standards and regulations (e.g. ISO 13485, 21 CFR 820, MDSAP, GMP)
  • Take an active part in all audits to fully represent the regulatory section

Ihr Anforderungsprofil.

Education

  • A minimum Bachelor’s degree is required, preferably in a science or engineering field.


Experience

  • At least 5 years of professional experience in international regulatory affairs management in the field of „in-vitro“ diagnostics or medical technology.
  • At least 3 years of leadership experience in RA/QA, positive leadership and team spirit


Knowledge, Skills, Abilities

  • Proven knowledge and direct experience working with international regulations and standards (e.g. 21 CFR 820, additional national regulations and standards, EU IVDD/ IVDR, ISO 13485, MDSAP)
  • Excellent organizational and influencing skills, strong ability to prioritize to meet objectives
  • Detail- and solution-oriented, organized and accurate, successful in driving results.
  • High communicative and intercultural competence with strong written and oral communication skills. Ability to collaborate and communicate effectively both externally and throughout the organization in German and English.
  • Proficient in English and German, both written and spoken

Vorteile.

  • Employment with an innovative, future-oriented organization.
  • Outstanding career and development prospects.
  • Company pension scheme.
  • Exciting company culture which stands for integrity, intensity, involvement and innovation.

Region. Kategorie. Disziplin.

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