Regulatory and Human Research Affairs Manager
About the job
Ximedica, LLC is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, RI, Plymouth, MN, San Francisco, CA, Philadelphia, PA and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
We have a high-energy culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: The Regulatory and Human Research Affairs Manager is responsible for overseeing and providing expert advice on human research and regulatory projects, and training research and regulatory staff on Ximedica services. This position may also manage client relationships on regulatory projects. The position requires 10+ years of experience in regulatory affairs and experience with human research of medical products with a strong emphasis on medical devices, combination products, and IVD.
Nature of Role: The Regulatory and Human Research Affairs Manager reports to the Director of Clinical and Regulatory Affairs. The individual in this position will act in a lead role supporting research teams in the tactical planning and oversight of high quality, ethical and regulatory compliant human research projects. S/he will also act as a subject matter expert in regulatory affairs supporting product development teams, writing regulatory submissions or in direct communication with clients.
The individual in this position must have a deep understanding of FDA regulations and a strong understanding of how medical products are regulated in the U.S., the EU and other major market countries and human research methods.
- The candidate must:
- Have good written & oral communication skills and the ability to communicate appropriately with research and product development teams, clients, suppliers, FDA and company management.
- Be able to work both as an individual contributor and a member of a cross-functional team, to manage multiple responsibilities simultaneously and successfully meet high expectations and tight deadlines. Will be working on highly visible projects critical to product development.
- Minimum travel is required if a client needs a face-to-face meeting, in-person FDA meetings or research projects.
- Attain and maintain a level of product and application expertise to communicate effectively with development team members, supervisory staff, content experts and regulators.
- Oversee the preparation of human research study protocols and supporting documentation for evaluation of usability, product functionality or safety and effectiveness.
- Prepare well-reasoned and well-organized regulatory submission documents or document sections for submission directly or for submission by clients.
- Identify, report and work with program management to manage key issues affecting project completion and provide accurate and timely reports on project status.
- Interact with client representatives on a peer and non-peer level to foster a collaborative business relationship and advance product development program objectives.
- Assist in developing departmental objectives, plans, policies/procedures, resource and other requirements.
- Be able to contribute to projects that support wider organizational goals.
- Bachelor’s degree or higher in science, engineering or a health-related field.
- 10+ years of experience in regulatory affairs and knowledge of human research in medical products, including significant medical device, combination product experience, and IVD.
- Understanding of and experience in dealing with U.S. and EU medical device, combination product, and IVD regulations, including those pertaining to human use of investigational products.
- Experience with medical product-related human research submissions for external ethical and/or scientific review, including direct experience in the development of human research protocols, informed consent documents, case report forms and other components of an investigational study binder.
- Knowledge of human research and medical product regulation in major international market areas (US and OUS) sufficient to provide competent guidance to product development teams and perform required process steps for authorization to market new medical products (primarily medical devices and combination products).
- Experience with medical product development
- Good written and verbal communication skills and the ability to teach others
- Comfortable dealing with senior executives on strategic matters
- Strong interpersonal skills and the ability to plan, perform and instruct other team members in the tasks necessary for a human research or regulatory project
- Excellent written and verbal communication skills
- Strong computer skills with commonly used business software and applications
EQUAL OPPORTUNITY EMPLOYER
It is the policy of the ITEM Group (NPD, ICP, and Ximedica) to provide equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.
In addition you can apply directly via Careers on our Website: http://www.ximedica.com
Job posted: 2021-02-03