Senior Regulatory Affairs Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 10/11/2018

Job Snapshot

Job Description

Who we want

Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.

Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.

Achievers. Thrives on accomplishing tasks and constantly driven to do more.

Collaborators. Collaborates and builds relationships with internal and external stakeholders.

Communicators. Articulates well and expresses ideas effectively.

Learners. Great desire to learn and looks to continuously improve.

Responsibility:  Take ownership of what you say you will do. Committed to stable values such as honesty and loyalty.

Teammates. Supports, encourages, and inspires others.

What you will do

The Senior Regulatory Affairs Specialist is a collaborative team player interested in sitting in matrix project teams to provide sound and comprehensive regulatory strategies to bring product to market and executing through submissions. This position also supports maintenance endeavors to keep product on existing markets and assists affiliates during the registration process .  This role supports the review of marketing materials, collateral documents, and presentations used for training and education courses offered by Stryker Trauma & Extremities Division.

•510(k), IDE, PMA, CE Technical Documentation preparation, review and submission•Front facing with Regulatory Bodies or Agencies.•Proven ability to communicate with Salespersons and other key field personnel•Provide strategic direction on how to best streamline our process and use more of a risk-based approach to making decisions

What you need

•4 year degree; Engineering, Science, or Regulatory Affairs •3+ years of Experience within medical devices or regulated industry•Adaptable to a fast paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamically thriving environment•Strong interpersonal, written and oral communication skills•Good time and project management skills with the ability to multi-task•Strong leadership skills•Knowledge of the Quality Systems Regulation, ISO 13485, the Medical Device Directive/Medical Device Regulation, and applicable guidance documents for medical devices.

Work From Home: No

Travel Percentage: Up to 25%

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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