Stryker
Senior Manufacturing Engineer für Projekte – Produktion, Medizintechnik(m/w/x)
Full-timeWith HomeofficeSenior
Selzach
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STStryker
Senior Regulatory Affairs Specialist RA(m/w/x)
Selzach
Full-timeWith Home OfficeSenior
Nejo AI Summary
Bringing medical devices to market with global regulatory strategy development. Strategic thinking and data analysis skills required. Participation in cross-functional teams, fast-paced environment.
Requirements
- Self-directed and takes ownership
- Strategic thinking and data analysis
- Collaborative and cross-functional partnership
- Dedicated and thrives in fast-paced environment
- Goal-oriented and customer-focused development
- Bachelor's Degree in Science, Engineering or equivalent
- Minimum 3 years FDA/regulated industry experience
- Minimum 1 year Regulatory Affairs role
- Previous Class II/III medical devices experience preferred
- Previous 510(k) drafting experience preferred
- RAC certification or Advanced Degree preferred
- Experience authoring regulatory submissions preferred
- Experience interacting with regulatory agencies preferred
- Ability to comply with changing regulatory procedures
- Ability to analyze and resolve regulatory issues
- Excellent analytical and writing skills
- Excellent interpersonal, written, oral communication skills
- Effective organizational skills
- Advanced PC skills with Microsoft Office Suite
Tasks
- Bring medical devices to market
- Ensure ongoing compliance
- Participate in cross-functional teams
- Develop global regulatory strategies
- Author regulatory submissions
- Interact with regulatory agencies and notified bodies
- Review labeling and marketing materials
- Evaluate proposed device changes
- Assess regulatory intelligence
- Participate in advanced advocacy activities
- Evaluate regulatory environment
- Provide internal advice throughout product lifecycle
- Anticipate regulatory obstacles
- Develop solutions for regulatory issues
- Identify market access requirements
- Assist in regulatory strategy development
- Update regulatory strategy based on changes
- Evaluate products for regulatory classification
- Determine regulatory submission requirements
- Provide regulatory guidance for product development
- Compare regulatory outcomes with product concepts
- Recommend changes based on regulatory outcomes
- Negotiate with regulatory authorities
- Identify need for new regulatory procedures
- Participate in SOP development and implementation
- Train stakeholders on regulatory requirements
- Assist in SOP development for compliance
- Provide regulatory input on global requirements
- Advise on quality, pre-clinical, and clinical data requirements
- Assess acceptability of quality, pre-clinical, and clinical documents
- Evaluate pre-clinical, clinical, and manufacturing changes
- Propose plans for regulatory filing solutions
- Provide guidance on pre-approval inspections
- Monitor and submit reports to regulatory authorities
- Provide regulatory information for product claims
- Ensure clinical and nonclinical data consistency
- Prepare and submit regulatory submissions
- Monitor regulatory authority review progress
- Communicate with regulatory authorities
- Work with cross-functional teams for regulatory interactions
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office Suite
- Excel
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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STStryker
Senior Regulatory Affairs Specialist RA(m/w/x)
Selzach
Full-timeWith Home OfficeSenior
Nejo AI Summary
Bringing medical devices to market with global regulatory strategy development. Strategic thinking and data analysis skills required. Participation in cross-functional teams, fast-paced environment.
Requirements
- Self-directed and takes ownership
- Strategic thinking and data analysis
- Collaborative and cross-functional partnership
- Dedicated and thrives in fast-paced environment
- Goal-oriented and customer-focused development
- Bachelor's Degree in Science, Engineering or equivalent
- Minimum 3 years FDA/regulated industry experience
- Minimum 1 year Regulatory Affairs role
- Previous Class II/III medical devices experience preferred
- Previous 510(k) drafting experience preferred
- RAC certification or Advanced Degree preferred
- Experience authoring regulatory submissions preferred
- Experience interacting with regulatory agencies preferred
- Ability to comply with changing regulatory procedures
- Ability to analyze and resolve regulatory issues
- Excellent analytical and writing skills
- Excellent interpersonal, written, oral communication skills
- Effective organizational skills
- Advanced PC skills with Microsoft Office Suite
Tasks
- Bring medical devices to market
- Ensure ongoing compliance
- Participate in cross-functional teams
- Develop global regulatory strategies
- Author regulatory submissions
- Interact with regulatory agencies and notified bodies
- Review labeling and marketing materials
- Evaluate proposed device changes
- Assess regulatory intelligence
- Participate in advanced advocacy activities
- Evaluate regulatory environment
- Provide internal advice throughout product lifecycle
- Anticipate regulatory obstacles
- Develop solutions for regulatory issues
- Identify market access requirements
- Assist in regulatory strategy development
- Update regulatory strategy based on changes
- Evaluate products for regulatory classification
- Determine regulatory submission requirements
- Provide regulatory guidance for product development
- Compare regulatory outcomes with product concepts
- Recommend changes based on regulatory outcomes
- Negotiate with regulatory authorities
- Identify need for new regulatory procedures
- Participate in SOP development and implementation
- Train stakeholders on regulatory requirements
- Assist in SOP development for compliance
- Provide regulatory input on global requirements
- Advise on quality, pre-clinical, and clinical data requirements
- Assess acceptability of quality, pre-clinical, and clinical documents
- Evaluate pre-clinical, clinical, and manufacturing changes
- Propose plans for regulatory filing solutions
- Provide guidance on pre-approval inspections
- Monitor and submit reports to regulatory authorities
- Provide regulatory information for product claims
- Ensure clinical and nonclinical data consistency
- Prepare and submit regulatory submissions
- Monitor regulatory authority review progress
- Communicate with regulatory authorities
- Work with cross-functional teams for regulatory interactions
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office Suite
- Excel
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Stryker
Industry
Healthcare
Description
Das Unternehmen ist ein globales Medizintechnikunternehmen, das hochwertige Implantate für den Bereich Trauma & Extremities fertigt.
Not a perfect match?
- Stryker
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