Regulatory Affairs Support Manager (m/w/d) North America

• Support RA/QMS North America impact assessment for FDA and Health Canada submissions through data review of labeling, risk, V&V, design, new development and change control initiatives
• Identify and escalate regulatory risks from changes and improvement initiatives
• Identify and implement process initiatives to proactively align with SE regulatory product lifecycle needs and North America regulatory timelines
• Maintain oversight and communicate changes impacting North America regulatory documentation
• Coordinate and support information and communication between the SE and US cross-functional teams
• Promote consideration of North American priorities and requirements
• Support SE workload in North American priority projects where needed (i.e. gap assessments, Risk file documentation and review, meeting support)
• Cultivate strategic partnerships across departments to support regulatory objectives and broader organizational goals
• Monitor the evolving regulatory landscape, interpreting changes in regulations and guidance relevant to company products and advising on necessary actions
• Promote and maintain positive, collaborative relationships across teams and with external regulatory bodies to support successful submission outcomes
• Performs other related duties and responsibilities, on occasion, as assigned
• Bachelor’s degree in a technical or scientific discipline
• Experience in medical device regulatory affairs
• Regulatory expertise of FDA, Health Canada, EU MDR, ISO 13485
• Fluency in German and English
• Strong cross-functional collaboration and organizational skills
• High integrity and ability to maintain confidentiality of company and department information
• Ability to work effectively with all levels of internal and external associates, customers, and colleagues
• Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
• Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
• Ability to work with minimal supervision
• Ability to manage multiple priorities
• Ability to work both independently and within a team environment
• Possess intermediate to advanced level knowledge of Microsoft Office and ERP systems

Was wir bieten

Jeden Tag ein bisschen besser werden. Nicht aufhören, sich Ziele zu setzen. Mit Sportlichkeit und Beharrlichkeit Entwicklungen vorantreiben, um Neues zu schaffen. Mit Kreativität, Weitblick und Passion. Das ist der Geist, der KLS Martin voranbringt. Als erfolgreiches Familienunternehmen legen wir, neben der fachlichen Kompetenz, besonderen Wert auf spürbare Nähe, gelebte Fairness und aufrichtigen Respekt im Umgang mit unseren Kunden und Kollegen.
Wir bieten ein gestalterisches Arbeitsumfeld in einem motivierten und anpackenden Team sowie Aufgabenstellungen, die vielschichtig und abwechslungsreich sind. Darüber hinaus bieten wir Ihnen eine leistungsgerechte Vergütung, ein angenehmes Betriebsklima und attraktive Sozialleistungen in einem modernen und technisch sehr gut ausgestatteten Unternehmen.
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