Senior Post Market Surveillance Analyst

Senior Post Market Surveillance Analyst

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 include creating and maintaining post market surveillance plans and reports with cross functional teams 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 include a 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 include 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.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect : Health and wellness : comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents. Financial security : a competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services. Work-life balance : generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available. Professional development : opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement. Recognition and rewards : recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events. Community and culture : a supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way. Competitive compensation : the compensation range for this position is $88,239 - $132,358. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and / or incentives. Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.