Senior Staff RA Specialist (Hybrid)

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We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Instruments division based hybrid two to three days per week in Portage, MI.

Who we want

· Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

· Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

· Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

What you will do

As the Senior Staff Regulatory Affairs Specialist , you will support new product development for both domestic and international release contributing to the development and updating of regulatory strategy based upon regulatory changes. You will play an integral role ensuring compliance by completing thorough assessments pertaining to product clearances/approval by the FDA, Notified Bodies, and other regulatory bodies.

Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature

Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance

Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)

Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

Evaluates proposed products for regulatory classification and jurisdiction

Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes

Negotiates with regulatory authorities throughout the product lifecycle

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

Assists other departments in the development of SOPs to ensure regulatory compliance

Provides regulatory input and technical guidance on global regulatory requirements to product development teams

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

Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships

Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

Provides regulatory information and guidance for proposed product claims/labeling

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

Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need

Bachelors Degree required; preferably in Engineering, Science, or related area

RAC preferred

Minimum 6 years of full-time work experience in an FDA regulated environment required

Minimum 4 years of full-time work experience in medical device regulatory affairs required

Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.