Staff Regulatory Affairs Specialist
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 Staff Regulatory Affairs Specialist to join Stryker’s Orthopedic Instruments or Surgical Technologies businesses at our Instruments division based in Portage, Michigan or remotely anywhere within the United States.
Stryker’s Orthopedic Instruments business delivers innovative products and services for the Orthopaedic ecosystem, and Stryker’s Surgical Technologies business enables caregivers to provide a safer, simple experience for their patients. Learn more at: https://bit.ly/3lPW6sv and https://bit.ly/2YVOXND and https://bit.ly/32JKqPll
Who we want
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- 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.
- 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.
- Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do
As a Staff Regulatory Affairs Specialist, you can expect to set Global RA strategy for new product development portfolios. You 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 also ensure regulatory compliance by completing through assessments and the appropriate submissions pertaining to product clearances or approvals by FDA, Notified Bodies and other regulatory bodies. In this role, you are the Stryker Instruments division subject matter expert for the regulatory and business requirements. You are actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business and organizational activities, management and strategy. Expect to launch new devices, author regulatory submissions and advise new product development teams. Imagine setting your own RA strategy, not inheriting one, and seeing the device portfolio stand on your strategy for years to come! This is a unique opportunity to create a legacy.
Responsibilities may include:
- Providing strategic input and technical guidance on regulatory requirements
- Assisting in the development and update of regulatory strategy and SOPs
- Providing regulatory input for new product development and product lifecycle planning
- Evaluating regulatory impact of proposed changes to launched products
- Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
- Determining and communicating submission and approval requirements
- Participating in risk-benefit analysis for regulatory compliance
- Revisiting and comparing regulatory outcomes with initial product concepts to make recommendations on future actions
- Maintaining annual licenses, registrations and listings
- Reviewing regulatory aspects of contracts
- Ensuring compliance with product post-approval or clearance requirements
- Approving labeling, advertising and promotional items for compliance
- Reviewing publicly disseminated information to minimize regulatory exposure
- Reviewing product claims and preserving confidentiality of applicable product information
- Providing regulatory input for and appropriate follow-up to inspections and audits
- Assisting in the development and implementation of SOPs and systems to track and manage product-associated events
- Reviewing change management to determine the level of change and potential submission requirements
- Identifying product-associated problems and developing proposals for solutions
- Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study or marketing applications
- Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
- Monitoring impact of changing regulations on submission strategies and identifying issues early in the submission preparation process that could impact product launch
- Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
- Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance
What you need
- Bachelor’s degree in Engineering, Science, Regulatory or equivalent focus
- Minimum 5 years professional experience with at least 3 years direct regulatory affairs experience within the medical device or pharmaceutical industry
- General understanding of product development process and design control Thorough understanding of FDA and international medical device regulations
- Effective communicator and consensus-builder
- Ability to comply with constantly changing regulatory procedures and prioritize
- Ability to analyze and resolve non-routine regulatory issues using independent judgement
- Demonstrated analytical, interpersonal, writing and organizational skills
You may also have
- Advanced degree; Masters in Regulatory Affairs
- Regulatory Affairs Certification (RAC) or applicable professional certification
- Experience with medical devices and drafting 510(k)s
- Experience authoring regulatory submissions for product approval and interaction with regulatory agencies
Work From Home: RemoteTravel Percentage: 20%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.
Job posted: 2020-09-22