Senior Regulatory Affairs SpecialistStryker. - Tempe, AZ
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. 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. Stryker products and services are available in over 100 countries. All 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.
Job Description / Information
Managing the preparation, review, and submission of pre-market submissions, technical files, and design dossiers, including establishing and maintaining necessary written procedures, such as for submission review, applications, CE marking and clearance.
Serve as a Regulatory representative on new product development and sustaining engineering project teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
Responsible for reviewing and approving product and manufacturing changes for compliance with applicable regulations and developing and implementing departmental and divisional policies and procedures to ensure assessment of significant changes.
Interface with key staff members in strategic planning, product development, operations, and customer service departments to meet scheduled regulatory submission and approval dates.
Maintain and/or develop cordial relations with counterparts and officials in federal and state government and international regulatory agencies.
Evaluate data generation carefully in line with scientific principles and company policies. Review and edit materials to meet U.S. and OUS regulatory requirements and company policy.
Participate in the development of product labels and labeling, particularly Instruction For Use documents while considering global labeling requirements.
Review and approve labeling, advertising, and promotional materials including web-based materials for compliance with regulations, and ensure that product claims are consistent with premarket clearances.
Participate in activities of the Association of Medical Device Reprocessors in reviewing and responding to FDA and international government agency proposals for regulation of medical device reprocessing.
Participate in Risk Management and post-market surveillance as part of cross-functional teams.
Review and approve document action requests and process change orders.
Perform recalls and sub-recalls.
Respond to Customer/Sales representative questions and issues.
Inform department director when significant deviations occur from planned submission schedule or when testing or labeling will be unlikely to meet regulatory requirements.
Assist with the development and maintenance of documented regulatory procedures as required to assure consistent and compliant regulatory activities.
Assist with maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
Participate in new business development activities and ensure applicable US and OUS regulatory activities are being addressed.
Bachelor’s degree required, life science or engineering discipline is preferred.
3 - 5 years’ experience in regulatory areas.
Extensive experience with FDA regulations and compliance.
Quality Assurance/Regulatory experience in class II medical devices.
Expertise with 510(k) submissions.
Ability to manage the regulatory functions, as well as involvement in key projects.
Ability to interface with both technical and non-technical personnel.
Ability to work effectively in a team environment with shifting priorities and timeliness requirements.
Possesses excellent interpersonal, analytic, and problem-solving skills.
Possesses strong interpersonal and persuasive skills.
Proficient in Microsoft Word, Excel, Power Point, Outlook.
Exposure to JD Edwards (One World) and Business Objects preferred.
Production / Cleanroom at times
While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.
The employee may occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
While performing the duties of this job, the employee is exposed to weather conditions prevalent at the time.
The noise level in the work environment is usually moderate.
May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.
Required at times to wear Personal Protective Equipment to protect against exposure to Bloodborne pathogens and chemicals.
9 days 9 hours ago
applySenior Regulatory Affairs Specialist Stryker. - Tempe, AZ, United States
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
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