CORK, CO, T23, IE
Job details
Work flexibility: Hybrid
Req ID: R541897
Employee type: Full Time
Job category: RAQA
Travel:
Relocation: No
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Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
Key Areas of Responsibility:
- Evaluates the regulatory environment and provides internal advice for proposed device changes to ensure product compliance
- Supports a broad portfolio of orthopaedic implants and instruments across Stryker global manufacturing sites
- Evaluates proposed design and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
- Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
- Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Collaborates with project teams, provides technical guidance and advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
- Monitors the progress of the regulatory authority review process through appropriate communications with the authorities
Education / Work Experience:
- BS in Engineering, Science, or related or MS in Regulatory Science
- 2+ yrs experience
- RAC(s) preferred
Knowledge / Competencies:
- General understanding of product development process and design control.
- Understanding of FDA, Europe and international medical device regulations required.
- Previous experience with Class II/III medical devices preferred.
- Previous experience drafting 510(k)s and EU submissions preferred.
- Experience interacting with regulatory agencies preferred.
- Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
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Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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