Project Manager – Medical Device Certification

Job Description: • Contribute to a safe and healthy work environment by actively participating, taking responsibility, and following established procedures and policies. • Access and review client’s medical device files for regulatory requirement for European markets. • Utilize knowledge of regulatory requirements and apply to manufacturers’ processes and products. • Audit manufacturers ensuring continued compliance to MDD, AIMD, IVD, MDR, IVDR, etc. • Review product design, documenting any deficiencies, review engineering and manufacturing using STED formats. • Audit experience to include ISO 13485 and MDSAP. • Create reports for clients utilizing analytical skills, technical knowledge, and excellent written communication skills. • Utilize professional presentation skills while meeting with clients to present DEKRA’s findings. • Work with minimal supervision, able to assess compliance to the regulatory requirements. • Analyze complex regulatory requirements and make sound determinations of the proper course of action. • Work with external consultants utilizing positive interactive skills. Requirements: • Education: Minimum 4-year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics, or related discipline of medical devices. • MS degree or PhD in related field preferred but not required. • Minimum of 7-10 years in a similar role in the Notified/Accreditation Body Industry, or combination of education and experience in the Medical Device field. • Strong background in either design engineering or R & D. • Global Regulatory Affairs background including CE Medical Device Directives. • Experience with one or more MDD, AIMD, IVD, MDR, IVDR. • Broad background in medical devices. • Broad knowledge of engineering and technical applications used in the development of medical devices. • Excellent interpersonal, verbal, written and presentation skills. • Must work well in project teams. • Strong analytical skills while handling multiple projects, delivering results on time using well developed problem-solving skills. • Pro-active attitude and excellent organizational skills and the ability to work autonomously. Benefits: • Health care benefits: medical & prescription, dental, vision (including Domestic Partners) • Critical Illness & Hospital Indemnity supplemental insurance • Company Health Savings Account contribution • Flexible Spending Account for eligible health care and dependent care expenses • Paid time off such as vacation, sick leave, and floating holidays • Mental and emotional support resources through our Employee Assistance Program • Wellness Program to increase activity and health habits, with ability to earn participation rewards • Paid Parental Leave • Travel Assist (Domestic/International) • Participation in a 401(k) plan, with an employer match • Company paid Short- & Long-Term Disability benefits • Group term life insurance with options to buy-up for self and others • Tax-free Service Awards • Education Assistance Program • Student Loan Repayment Assistance • Internal training and development resources to grow your career • LEAD Forward Leadership Development Program • Annual Career Goal Setting and Performance Review cycle participation Apply tot his job