Sr Specialist Post Market Surveillance, EMEA

Job description

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The position supports the effective implementation of Integra's Post Market Compliance systems including Medical Device Vigilance Reporting processes based on international requirements. The position requires participation in and at times lead activities that identify, assess and determine the level of patient and/or compliance risk associated with Integra products in the marketplace. RESPONSIBILITIES Evaluate complaints recorded in the complaint database by Complaint department and decide if recorded events are reportable according to European regulation. Complete the decision tree and justify the decision with the help of various departments and manufacturing sites if needed. Prepare Manufacture Incident Report for medical device vigilance and submit to regulatory authorities. Prepare Authorities Inquiry response with manufacturing site support when needed and submit to regulatory authorities on time. Support other European Medical Specialists in vigilance decision or reporting if needed. Provide support and/or participate in regulatory audits/inspections as required. Represent Integra in MEDTECH and SNITEM PMS working group. Participate in meetings and transfer information to Integra Stakeholders. Write and or revise department procedures as needed. Keep apprised of new regulations standards, policies, and guidance documents issued by relevant regulatory authorities that may impact vigilance. Perform all other related duties as directed by management. QUALIFICATIONS Bachelor's degree in science or other technically related field, or equivalent work experience. 3-5 years’ experience in a medical device or pharmaceutical company responsible for administration of quality engineering activities specifically those related to the assessment of risk and recalls, preferred Knowledge on ISO13485, applicable MEDDEVs, MDR... ASQ Quality Engineer and/ or Regulatory Affairs Certified (CE/ RAC) preferred Computer skills to include knowledge and proficiency with Excel, Sharepoint and proficient use of the worldwide web network. Strong writing, project management, problem solving, and communication skills Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.