Post-Market Surveillance Specialist
Schaumburg, IL
Full Time
Mid Level
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 Post-Market Surveillance Specialist 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 Post-Market Surveillance Specialist will play an important part in helping us grow.
This position will plan and oversee Post Market Surveillance processes and assist with Clinical Evaluation Reports throughout the product life cycle.
Salary range: $78K-$92.6K, 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 Post-Market Surveillance Specialist:
The job responsibilities of this position may include, but are not limited to:
Bisco, Inc. stands out because of our culture and core values:
Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday
EOE
No agencies please.
BISCO is seeking an ambitious medical writer for the role of Post-Market Surveillance Specialist 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 Post-Market Surveillance Specialist will play an important part in helping us grow.
This position will plan and oversee Post Market Surveillance processes and assist with Clinical Evaluation Reports throughout the product life cycle.
Salary range: $78K-$92.6K, 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 Post-Market Surveillance Specialist:
The job responsibilities of this position may include, but are not limited to:
- Plan, author, and maintain the reports, and the corresponding plans, for post-market surveillance activities: Post-Market Surveillance (PMSP/PMSR), Periodic Safety Update (PSUP/PSUR), Post-Market Clinical Follow-Up (PMCFP/PMCF).
- Review and help provide guidance on the Clinical Evaluation Reports (CERs)
- Author the 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.
- Monitor post-market surveillance and clinical regulatory requirements and trends as part of the Regulatory Intelligence process.
- Participate in the development of regulatory responses for Notified Body submission questions.
- Participate in the risk management process ensuring input of clinical and PMS data to the process.
- Provide guidance on the development and implementation of global clinical regulatory strategies for new and legacy devices.
- 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 Post-Market Surveillance reports preferred.
- Detailed knowledge of relevant MDCG guidance preferred.
- Familiarity with relevant international regulatory requirements and guidance documents for medical devices, including MEDDEV 2.7/1 revision 4
- 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
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!
Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday
EOE
No agencies please.
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