Coloplast
Senior Post Market Surveillance Analyst
Coloplast, Minneapolis, Minnesota, United States, 55400
Senior Post Market Surveillance Analyst
Location: Minneapolis, MN, US
Job Family: Quality Assurance
Country/Region: United States
This position is essential to the compliance of the company with FDA and international regulatory authorities. This position is responsible for supporting the post market surveillance activities for Interventional Urology (IU) Business Unit.
Major Areas of Accountability
Responsible for creating and maintaining Post Market Surveillance plans and reports with cross functional team for the IU Business Unit in accordance with applicable regulations (i.e. EU 2017/745)
Compile and analyze complaint data for reports such as Clinical Evaluation Report (CER) or country submissions
Complete trend review analysis for EU 2017/745 and present outcome to a cross functional team for a reporting decision
Alert Quality Management of unusual trends during post market activities and coordinate cross functional input as needed
Contribute to the development and optimization of methods and procedures for effective post market activities and trending
Support monthly Product Review presentations as required
Support internal and external audits as required
Support complaint intake as required
Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
Other job duties as assigned.
Basic Qualifications
Bachelor's Degree required.
Degree in a technical or life sciences discipline is desired.
5+ years related experience and/or relevant training.
Strong post market surveillance background.
Experience in regulatory affairs, quality assurance, or complaint handling in the medical device industry is desired.
Experience with Class II and Class III implantable medical devices is desired.
Knowledge, Skills & Abilities
Excellent verbal and written English communication skills.
Excellent analytical skills.
Structured and methodical problem-solving approach.
Knowledge and application of FDA, MDSAP, EU MDR, ISO 13485 and ISO 14971 requirements.
Strong attention to detail and deadline oriented.
Intermediate to advanced level expertise using MS Office applications (Word, Excel, PowerPoint) and Statistical Analysis software.
Ability to work individually and as a team leader.
Ability to multi-task.
Basic to intermediate statistical knowledge.
Benefits and Compensation
Health and Wellness: Comprehensive medical, dental, and vision insurance plans; wellness programs and mental health resources; paid leave of absence for qualifying events; parental leave for both birthing and non-birthing parents.
Financial Security: Competitive 401(k) plan with company match; financial planning services; corporate discount programs.
Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options.
Professional Development: Training programs, mentorship, and tuition reimbursement.
Recognition and Rewards: Recognition programs, bonuses, awards, and events.
Community and Culture: Supportive work environment with team-building, volunteer opportunities, and sustainability initiatives.
Competitive Compensation: The compensation range for this position is $88,239 - $132,358. Hiring may include bonuses and/or incentives.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Coloplast is committed to a policy of Equal Employment Opportunity (EEO).
Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
Visit us on Coloplast.com. Watch the film. Follow us on LinkedIn. Like us on Facebook.
Coloplast is one of the world’s leading medical device companies, employing about 16,000 people with products available in more than 143 countries.
59835
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This position is essential to the compliance of the company with FDA and international regulatory authorities. This position is responsible for supporting the post market surveillance activities for Interventional Urology (IU) Business Unit.
Major Areas of Accountability
Responsible for creating and maintaining Post Market Surveillance plans and reports with cross functional team for the IU Business Unit in accordance with applicable regulations (i.e. EU 2017/745)
Compile and analyze complaint data for reports such as Clinical Evaluation Report (CER) or country submissions
Complete trend review analysis for EU 2017/745 and present outcome to a cross functional team for a reporting decision
Alert Quality Management of unusual trends during post market activities and coordinate cross functional input as needed
Contribute to the development and optimization of methods and procedures for effective post market activities and trending
Support monthly Product Review presentations as required
Support internal and external audits as required
Support complaint intake as required
Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
Other job duties as assigned.
Basic Qualifications
Bachelor's Degree required.
Degree in a technical or life sciences discipline is desired.
5+ years related experience and/or relevant training.
Strong post market surveillance background.
Experience in regulatory affairs, quality assurance, or complaint handling in the medical device industry is desired.
Experience with Class II and Class III implantable medical devices is desired.
Knowledge, Skills & Abilities
Excellent verbal and written English communication skills.
Excellent analytical skills.
Structured and methodical problem-solving approach.
Knowledge and application of FDA, MDSAP, EU MDR, ISO 13485 and ISO 14971 requirements.
Strong attention to detail and deadline oriented.
Intermediate to advanced level expertise using MS Office applications (Word, Excel, PowerPoint) and Statistical Analysis software.
Ability to work individually and as a team leader.
Ability to multi-task.
Basic to intermediate statistical knowledge.
Benefits and Compensation
Health and Wellness: Comprehensive medical, dental, and vision insurance plans; wellness programs and mental health resources; paid leave of absence for qualifying events; parental leave for both birthing and non-birthing parents.
Financial Security: Competitive 401(k) plan with company match; financial planning services; corporate discount programs.
Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options.
Professional Development: Training programs, mentorship, and tuition reimbursement.
Recognition and Rewards: Recognition programs, bonuses, awards, and events.
Community and Culture: Supportive work environment with team-building, volunteer opportunities, and sustainability initiatives.
Competitive Compensation: The compensation range for this position is $88,239 - $132,358. Hiring may include bonuses and/or incentives.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Coloplast is committed to a policy of Equal Employment Opportunity (EEO).
Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
Visit us on Coloplast.com. Watch the film. Follow us on LinkedIn. Like us on Facebook.
Coloplast is one of the world’s leading medical device companies, employing about 16,000 people with products available in more than 143 countries.
59835
#J-18808-Ljbffr