Regulatory Affairs Specialist

Stryker Corporation; Cork; On-site; Confidential; Full time

Job summary

Stryker Ireland is seeking a Regulatory Affairs Specialist to contribute to global regulatory strategies and submissions for medical devices. You will interact with regulatory bodies, review labeling, and ensure compliance across US, EU, and other regions while working under supervision.

The role emphasizes collaboration with global affiliates, participation in development teams, and ongoing regulatory support for launched products and changes. Hybrid work flexibility is offered in Ireland.

Qualifications

• Bachelor's degree in Engineering, Science, or equivalent field.
• 1-2 years in a Regulatory Affairs role.

Responsibilities

• Work with supervision, conferring with more senior staff when indicated.
• Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.
• Evaluate medical device regulations and develop strategies for bringing products to market.
• Contribute towards obtaining US and EU regulatory approvals by authoring, compiling, and submitting premarket regulatory applications.
• Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
• Assess global impact of changes to launched products and support notifications/submissions as required.
• Review labeling and marketing literature for compliance with regulatory requirements.
• Determining and communicating submission and approval requirements
• Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
• Interfacing and coordinating directly with FDA, Notified Body reviewers, and other regulatory agencies on submissions, approvals or other issues.
• Reviewing and approving change documentation for regulatory impact on launched products.
• Providing regulatory input for and appropriate follow-up to inspections and audits
• Reviewing and approving labeling, advertising and promotional items for compliance before release
• Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products.
• Providing regulatory input for NCs.
• Preparing and updating US product registrations and listings
• Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy.
• Participating in process improvement activities and projects.
• Assisting in complex projects and performing delegated tasks as required.
• Assisting with product post-market or clearance requirements (progress reports, annual reports etc.)
• Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
• Identifying issues early in the submission preparation process that could impact product launch
• Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members.
• Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence.

Education

Bachelor's degree in Engineering, Science, or equivalent field

Job description

Work Flexibility: Hybrid

The Regulatory Affairs Specialist works closely under direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes.

General Responsibilities:

• Work with supervision, conferring with more senior staff when indicated. Keep supervisor regularly apprised of project status.
• Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.
• Evaluate medical device regulations and develop strategies for bringing products to market.
• Contribute towards obtaining US and EU regulatory approvals by authoring, compiling, and submitting premarket regulatory applications.
• Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
• Assess global impact of changes to launched products and support notifications/submissions as required.
• Review labeling and marketing literature for compliance with regulatory requirements.

Additional tasks may include:

• Determining and communicating submission and approval requirements
• Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
• Interfacing and coordinating directly with FDA, Notified Body reviewers, and other regulatory agencies on submissions, approvals or other issues.
• Reviewing and approving change documentation for regulatory impact on launched products.
• Providing regulatory input for and appropriate follow-up to inspections and audits
• Reviewing and approving labeling, advertising and promotional items for compliance before release
• Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products.
• Providing regulatory input for NCs.
• Preparing and updating US product registrations and listings
• Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy.
• Participating in process improvement activities and projects.
• Assisting in complex projects and performing delegated tasks as required.
• Assisting with product post-market or clearance requirements (progress reports, annual reports etc.)
• Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
• Identifying issues early in the submission preparation process that could impact product launch
• Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members.
• Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence.

Minimum Requirements:

Bachelor's degree in an Engineering, Science, or equivalent field. 1-2 years in a Regulatory Affairs role.

#IJ Ireland Pay Ranges: Ireland: €42,000 - €71,000 EUR Annual. At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker's comprehensive benefits package.

Travel Percentage:

None

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces!

For more information, visit: www.stryker.com

Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.