· To develop and write clinical evaluation reports (CER) for pre- and post-market devices, while ensuring consistency with regulations, quality standards, commitments and goals.
· Writing coherent, convincing CERs by organizing and evaluating large amounts of scientific/clinical/medical data.
· Managing CER writing by planning, identifying, appraising and analyzing clinical data then writing the CER including conclusions based on expert knowledge.
· Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust CERs and other documents
· Assisting with other clinical, regulatory, quality and engineering projects as assigned
· Responsible to acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices
· Responsible to communicate scientific content in a clear, concise manner
· Other duties as assigned
· Must be focused, efficient, detail oriented and able to work independently.
· Able to read, analyze and implement regulations, standards and guidance.
· Demonstrated ability to manage projects (take minutes, multi-task, prioritize and ensure reliability and quality while executing projects on time and on budget).
· Strong written and oral communication skills.
· Bachelor's or Master’s Degree or PhD (preferred) in a scientific discipline.
· At least 3+ years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4.
· At least 3+ years clinical, regulatory, quality and/or engineering work experience.
· Able to productively interact with teams including corporate executives, research sites and research subjects.
· Advanced computer skills with Word, Excel, PowerPoint, etc.
· Fresh Perspectives
· Enhanced Skills and Expertise
· Increased Productivity
· Improved Morale
· Broadened Network
· Diversity and Inclusion
· Knowledge Transfer
Requirements
· Must be focused, efficient, detail oriented and
able to work independently.
· Able to read, analyze and implement regulations,
standards and guidance.
· Demonstrated ability to manage projects (take minutes,
multi-task, prioritize and ensure reliability and quality while executing
projects on time and on budget).
· Strong written and oral communication skills.
· Bachelor's or Master’s Degree or PhD (preferred)
in a scientific discipline.
· At least 3+ years CER writing experience with
solid knowledge of Med Dev 2.7/1, rev 4.
· At least 3+ years clinical, regulatory, quality
and/or engineering work experience.
· Able to productively interact with teams
including corporate executives, research sites and research subjects.
· Advanced computer skills with Word, Excel,
PowerPoint, etc.
Benefits
· Fresh Perspectives
· Enhanced Skills and Expertise
· Increased Productivity
· Improved Morale
· Broadened Network
· Diversity and Inclusion
· Knowledge Transfer
Skills Required
- Bachelor's or Master's degree in a scientific discipline
- PhD in a scientific discipline
- At least 3 years of clinical evaluation report writing experience
- Solid knowledge of MEDDEV 2.7/1 Revision 4
- At least 3 years of clinical, regulatory, quality, and/or engineering work experience
- Ability to interpret and implement regulations, standards, and guidance
- Demonstrated project management ability, including multitasking, prioritization, meeting minutes, and delivering on time and budget
- Strong written and oral communication skills
- Ability to work independently and remain focused, efficient, and detail-oriented
- Ability to collaborate with corporate executives, research sites, and research subjects
- Advanced computer skills with Word, Excel, and PowerPoint
What We Do
Founded in 2006, Meril is an India-based global medical device company dedicated to innovating, designing, and manufacturing clinically relevant healthcare products. It develops vascular intervention, orthopaedic, diagnostics, endo-surgery, ENT, and robotic solutions, collaborating with physicians and global innovators to address unmet clinical needs. Through research, development, manufacturing, scientific communication, and distribution, Meril aims to alleviate human suffering and improve quality of life worldwide.
