Stryker Director, Regulatory Affairs in Tempe, Arizona
Develop and interpret regulatory requirements from global markets, recommend to Regulatory Affairs and Quality Assurance (RAQA) Management specific activities and resources required to support and execute strategies to further the global growth of the business
Represent Stryker in interactions with external organizations including the FDA and other global health authorities, sponsors, and other organizations; serve as a primary Regulatory contact during all premarket activities and work with Stryker organizations to support the regulatory approval and commercialization efforts in global markets.
Lead the team of RA specialists and ensure sound regulatory strategies and advice are being provided to meet the business objectives; recruit, develop, and mentor regulatory professionals.
Directs RA associates in the preparation of 510(k) s, Technical Files/Documentation, and documentation for OUS registrations.
Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated.
Serve as an internal resource to address and resolve any questions or issues of a regulatory nature; provide oversight to RA team to ensure that regulatory decisions are sound and in support of the strategic goals
Manage processes involved with maintaining annual licenses, registrations, listings
Manage collateral review process to ensure compliance and applicability of process based on business objectives
Participate in Notified Body and Health Authority inspections.
Participate in joint ventures with other companies to develop and address all necessary considerations involved with reprocessing single-use medical devices.
Participate in activities of the Association of Medical Device Reprocessors (AMDR) in reviewing and responding to FDA proposals for regulation of medical device reprocessing.
Work is performed without appreciable direction and exercises significant latitude in determining technical objectives of assignments; assignments are often self-initiated; determines and pursue courses of action necessary to obtain desired results.
Bachelor's degree in a scientific discipline, advanced degree preferred.
Minimum 9 to13 years of experience in regulatory affairs in the medical device, pharmaceutical, biotechnology, contract research, or similarly regulated industry.
Minimum of 4 years management experience, regulatory affairs management experience highly preferred
Demonstrated experience in preparing global regulatory submissions - 510(k), Technical Files, Design Dossiers.
Experience authoring 510(k), Class IIa/IIb technical files and design dossiers.
Experience with global regulations, including experience with FDA, Health Canada, CE Marking and Japan MHLW/PMDA.
Thorough knowledge of FDA, QSR and ISO standards, regulations and requirements
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.
Travel up to 25%
Work From Home: No
Travel Percentage: Up to 25%
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com