Regulatory Affairs Support Manager (m/w/d) North America
Developing surgical innovations is our passion. Our employees' expertise, motivation, and commitment are crucial to this. That is why we always look for people who set goals for themselves, develop ideas, and are open to new ideas. Become a part of surgical innovation and contribute to improving people's quality of life.
What we offer
- Individual onboarding
with onboarding program and personal mentor.
- Training and further education
for your personal development with our financial support.
- Flexible working
with flexitime and mobile working of up to 60%.
- Sports and health offers
such as BusinessBike, Hansefit, yoga and health days.
- Cafeteria
with free water, fruit basket and changing food offers.
- Pension offers
such as company pension scheme and capital-forming benefits.
- Growing family business
that stands for personal proximity, uncomplicated decision-making processes, security and stability.
- Innovation and exciting products
that often set new standards and help people.
Find out more
Your tasks
- 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.
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Identify and escalate regulatory risks from changes and improvement initiatives.
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Identify and implement process initiatives to proactively align with SE regulatory product lifecycle needs and North America regulatory timelines.
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Maintain oversight and communicate changes impacting North America regulatory documentation.
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Coordinate and support information and communication between the SE and US cross-functional teams.
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Promote consideration of North American priorities and requirements.
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Support SE workload in North American priority projects where needed (i.e. gap assessments, Risk file documentation and review, meeting support).
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Cultivate strategic partnerships across departments to support regulatory objectives and broader organizational goals.
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Monitor the evolving regulatory landscape, interpreting changes in regulations and guidance relevant to company products and advising on necessary actions.
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Promote and maintain positive, collaborative relationships across teams and with external regulatory bodies to support successful submission outcomes.
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Performs other related duties and responsibilities, on occasion, as assigned.
Your qualifications
- Bachelor’s degree in a technical or scientific discipline.
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Experience in medical device regulatory affairs.
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Regulatory expertise of FDA, Health Canada, EU MDR, ISO 13485.
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Fluency in German and English.
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Strong cross-functional collaboration and organizational skills.
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Maintains high integrity and confidentiality of company and department information
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Ability to work effectively with all levels of internal and external associates, customers, and colleagues
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Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
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Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
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Ability to work with minimal supervision
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Ability to manage multiple priorities
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Ability to work both independently and within a team environment
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Intermediate to advanced level knowledge of Microsoft Office and ERP systems
Interested?
Then, apply directly online here. Our employees value collegiality and cooperation within teams. We are looking for new team members, people with personalities who share our values and want to shape the future together.
