Senior Specialist Regulatory Affairs (Remote) (R448217)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
What 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 managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
What You Will Do
The Sr. RA Specialist is involved with the regulatory practices associated with commercialization of medical devices.
Essential Duties and Responsibilities
- 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.
What You N
- Bachelor’s degree strongly 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.
- Travel 10%.
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