Project Manager – Medical Device Certification
DEKRA North America
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $126,000 - $168,000 per year
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory requirementsaudit experienceISO 13485MDSAPSTED formatsdesign engineeringR&Danalytical skillsproblem-solving skillsmedical device development
Soft skills
excellent written communication skillsprofessional presentation skillsinterpersonal skillsverbal communication skillsorganizational skillsability to work autonomouslypro-active attitudeteamworkanalytical skillsability to handle multiple projects