Senior Regulatory Affairs Specialist in Allendale, NJ at Stryker Corporation

Date Posted: 9/24/2020

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 Senior 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. 

  • 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.

  • 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 a Senior Regulatory Affairs Specialist, you can expect to set and execute RA strategy for changes made to the device post-launch to determine regulatory impact of changes to the current clearance/approvals. You also ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances or approvals by FDA, Notified Bodies and other regulatory bodies. You are actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business and organizational activities, management and strategy.

  • Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

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

  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

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

  • 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.

  • 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.

  • Assist other departments in the development of SOPs to ensure regulatory compliance.

  • Provide regulatory input and technical guidance on global regulatory requirements to product development teams.

  • Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

  • Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.

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

What you need

  • A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

  • A minimum of 3 years of experience in a FDA regulated industry required; preferably with medical devices.

  • A minimum of 2 years of Regulatory Affairs experience required.

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

  • General understanding of product development process and design control.

  • Thorough understanding of FDA and international medical device regulations.

  • Previous experience with Class II/III medical devices preferred.

  • Experience authoring regulatory submissions for product approval preferred.

  • Experience interacting with regulatory agencies preferred.

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

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

  • Excellent analytical and writing skills.

  • Excellent interpersonal, written and oral communication skills.

  • Effective organizational skills.

  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

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

  • Excellent analytical and writing skills.

  • Excellent interpersonal, written and oral communication skills.

  • Effective organizational skills.

  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

Work From Home: Occasional

Travel Percentage: None

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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