Senior Regulatory Affairs Specialist (Remote)

Work Flexibility: Remote or Hybrid or Onsite

What you will do

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, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

We are currently seeking a Senior Regulatory Affairs Specialist to join our Sustainability Solutions team; this position is Remote in the USA.

Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the Senior Regulatory Affairs Specialist for Stryker Sustainability Solutions, you will support vascular, surgical, and patient care product development and sustaining activities on cross-functional project teams for both US/FDA and global releases. You will be responsible for preparing complex submissions and/or presentations to regulatory agencies and for any related communications. You will also be responsible for anticipating regulatory hurdles and developing solutions and process improvements. You will work closely with cross-functional partners and communicate regulatory intelligence as well as evolving regulatory requirements to ensure product compliance.

Key Areas of Responsibility:

• Assesses regulatory intelligence, advises stakeholders of regulatory requirements, and participates in advocacy activities of a technical and/or tactical nature.
• Evaluates the regulatory environment throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) and helps train stakeholders on current and new regulatory requirements to ensure product compliance.
• Anticipates and develops solutions to regulatory obstacles and emerging issues and negotiates with regulatory authorities throughout the product lifecycle.
• Assists in the development of local, regional, and global regulatory strategies and updates strategy based upon regulatory changes.
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities, and provides regulatory information and guidance for product development and planning throughout the product lifecycle.
• Identifies the need for new regulatory as well as cross-functional procedures and SOPs and participates in development and implementation.
• Assesses the acceptability of documents (e.g., clinical/nonclinical data, claims/labeling) for maintenance and new product submissions, and provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
• 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 agency.

What you need

• A bachelor’s degree required. Bachelor’s degree in engineering, Science is preferred.
• A minimum of 3 years of experience in an FDA regulated industry required; preferably in Medical Device Regulatory Affairs, Quality, or Engineering role.
• 2+ years Regulatory Affairs experience required.
• 1+ years Medical Device experience preferred.
• General understanding of product development process and design control preferred.
• Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred.
• Technical writing experience preferred.

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.