Senior Regulatory Affairs Specialist (Remote)

Work Flexibility: Remote or Hybrid or Onsite

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 Specialist to join our Instruments Division to be based in Kalamazoo, Michigan or remote. As the Senior Regulatory Affairs Specialist, you will provide regulatory support in Stryker’s Craniomaxillofacial (CMF) business unit to obtain and maintain US and global market access. You will engage with 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.

What you will do

• Develop and implement processes involved with maintaining annual licenses, registrations, and listings
• Review and approve advertising and promotion to ensure regulatory compliance
• Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
• Provide regulatory input and appropriate follow-up for inspections and audits
• Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Negotiate with regulatory authorities throughout the product lifecycle
• Identify the need for new regulatory procedures, SOPs, and participates in development and implementation
• Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

      What you need

• A minimum of a bachelor’s degree (B.S. or B.A.) required, preferably in Science, Engineering or Regulatory.
• A minimum of 3-5 years of experience in a regulated manufacturing environment is required; preferably in a Regulatory or Quality role.
• Experience interacting directly with FDA and Global Regulatory Bodies, including audits and inspections is preferred.
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.

       Preferred

• Masters in Regulatory Affairs
• Knowledge of Class III Devices
• PMA
• Implantable Devices
• Patient Specific Devices
• RAC

• $75,300 - $120,700 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

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.

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