Regulatory Affairs Specialist in Allendale, NJ at Stryker Corporation

Date Posted: 11/16/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Regulatory Specialist to join our Spine Division to be based in Allendale, NJ.

Who we want

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

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

  • 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. 

  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality. 

What you will do

As the Regulatory Affairs Specialist you will support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Identify information sources and resources for local, regional, and global regulations.

  • Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information.

  • Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.).

  • Provide information used to evaluate proposed products for regulatory classification and jurisdiction.

  • Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities.

  • Assist in the development of regulatory procedures and SOPs.

  • Collect and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations.

  • Organize materials from preclinical and clinical studies for review and assists in the review process.

  • Compile and organizes materials for pre-submission reports and communications.

  • Assist in the preparation of dossiers and pre-submission and submission packages for regulatory agencies.

  • Track the status of applications under regulatory review and provides updates to the regulatory team.

  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.

  • Assist in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings.

What you need

  • A Bachelor’s Degree (B.S or B.A) required; Engineering or Science focus preferred.

  • A minimum of 1 year of experience in an FDA regulated industry required; preferably with medical devices.

  • A minimum of one year in a Regulatory Affairs, Quality or Engineering role preferred.

  • Previous experience with Medical Devices, Regulatory Affairs, Quality or Engineering required.

  • Excellent interpersonal, written English and oral communication skills.

  • Proficient in Microsoft Office Suite, including Word, Excel and PowerPoint.

  • Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred.

  • Ability to interface with both technical and non-technical personnel at all organizational levels.

  • Ability to understand and explain detailed regulatory compliance programs and/or issues.

  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.

  • Ability to communicate and network with regulatory personnel to obtain relevant information.

  • Regulatory Affairs Certification (RAC) preferred.

Work From Home: Occasional

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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