Post Market Surveillance Analyst
Job Description:
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You’ll Make in this Role
As a Post Market Surveillance Analyst you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
- Leading document creation for Post Market Surveillance activities including PMS Plans and review (PMS report/PSUR) records. Responsible for compiling data and preparing reports at periodic intervals as required by regulations.
- Leading the cross-functional team responsible for gathering data from multiple sources including Complaints, Field Safety Actions, Risk Management, Non-conformances and Validations for reporting. Perform required data analysis in applicable tools (Excel, Power BI or similar applications) to detect emerging trends of such issues that may require action and escalation to Senior Leadership.
- Partnering with product functional areas to ensure that Post Market Surveillance output is fed back into Research and Development, Design Quality, Supplier Quality, Risk Management and Marketing to achieve a closed-loop process.
- Supporting responses for additional information requests received from competent authorities, registries and notified bodies.
- Identification and escalation of quality issues as necessary.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
- Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution AND 3 years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment.
- High School Diploma/GED AND 7 years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment.
- Proficiency with Microsoft Office applications including Word, Excel and PowerPoint.
- Experience collaborating cross functionally to drive key initiatives or processes in a global, matrixed organization.
Additional qualifications that could help you succeed even further in this role include:
- Degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry, Engineering or related technical field is preferred.
- Demonstrated success in project management, teaming and influencing others to achieve results (Black belt, Green belt, PMP certification).
- Experience in Regulatory Affairs or Quality role in pharmaceutical, biological or medical device industry in a private, public, government or military environment.
- Understanding of the domestic and international requirements for post market surveillance such as ISO 13485/14971/20416, FDA Regulations (21 CFR (803, 806, etc.), CMDR, MDD and EU MDR.
- Experience analyzing data such as product complaints, clinical studies and competitive products using Power BI.
- Good written and verbal communication, problem solving and applied thinking skills.
- Well organized and able to multitask effectively.
Work location:
Travel: May include up to 5% domestic
Relocation Assistance: Is not authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only: The expected compensation range for this position is $95,825 - $117,120, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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