This position will have the option to work a hybrid schedule, with two days from home after three months of employment, with the remainder working in our office out of Schaumburg, IL.
BISCO is seeking an ambitious medical writer for the role of Clinical Reports Manager to join our thriving organization. We are an internationally recognized manufacturer of medical devices in the dental industry, specializing in the advancement and research of adhesive and composite technology. Our Clinical Reports Manager will play an important part in helping us grow.
This position will plan and oversee Clinical Evaluation Reports and assist with Post Market Surveillance processes throughout the product life cycle.
Salary range: $87K-$102K, commensurate with experience
Benefits: Medical, dental, and vision insurance, HRA and FSA, short and long-term disability, life insurance, PTO, 401(k) profit-sharing with match, potential year-end bonuses.
RESPONSIBILITIES of the Clinical Reports Manager:
The job responsibilities of this position may include, but are not limited to:- Provide guidance on the development and implementation of global Clinical Regulatory strategies for new and legacy devices.
- Scope, plan, author, and maintain Clinical Evaluation Reports and Summary of Safety and Clinical Performance (SSCPs).
- Assist in the review of General Safety and Performance Requirements and Essential Principles in design and development.
- Interprets results in preparation for product applications by evaluating clinical, scientific, risk data, and literature while staying abreast of current clinical practice
- Conduct and oversee literature searches for state of the art, clinical research, and post market surveillance.
- Participate in planning, authoring, and maintenance of post market surveillance reports, Periodic Safety Update Reports, and Post Market Clinical Follow-up reports.
- Participate in the risk management process ensuring input of clinical and PMS data to the process.
- Participate in the development of regulatory responses for Notified Body submission questions.
- Monitor clinical regulatory requirements and trends as part of the Regulatory Intelligence process.
Requirements:- Bachelor’s degree required. Advanced degree preferred. Degree in science, medicine, dentistry, or similar discipline highly preferred.
- Minimum of 5 years professional experience including medical/technical writing experience.
- Experience authoring, EU MDR compliant, medical device Clinical Evaluation Reports preferred.
- Detailed knowledge of MEDDEV 2.7/1 revision 4 and relevant MDCG guidance.
- Familiarity with relevant international regulatory requirements and guidance documents for medical devices
- Experience conducting systematic literature reviews, including the ability to formulate effective search strategies and apply inclusion/exclusions criteria.
- Familiarity applying research methodology and information management.
- Experience in the medical device industry, within a Quality Management System preferred
- Proficient in MS Office applications (Word and Excel) and email systems.
- Strong organizational and follow-up skills, as well as attention to detail.
- Strong English writing and communication skills
Why BISCO, INC.?
Bisco, Inc. stands out because of our culture and core values:- Respectful – Professional. Humble. Considerate.
- Positive – Friendly. Inclusive. Curious.
- Team Player – Helpful. Cooperative. Flexible.
- Agility of a small company but the stability of a big company
- Industry-leading dental restorative products
- Broad exposure to activities across the company
- Family-oriented environment with positive team players
- Approachable, respectful, and down-to-earth people
- Long-tenured employees to whom the leadership is committed
- Employees feel valued and are proud to be a part of the company
- Monthly whole-company fun events!
Since 1981, BISCO has provided innovative medical and dental products to dental customers around the world. Our primary focus is adhesive and composite technology. Located northwest of Chicago in Schaumburg, our advanced research facility includes on-site ISO 13485 certified manufacturing. Our privately-owned organization provides the opportunity for a close-knit environment that encourages inter-departmental collaboration. For more about us, please visit our website at www.bisco.com.
Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday
EOE
No agencies please. |
