At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Senior Clinical Eval Medical writer to support CER & PSUR for Surgical OU
Responsibilities may include the following and other duties may be assigned
- This role predominantly focuses on writing, editing and reviewing regulatory (e.g., Clinical Evaluation Reports/clinical study reports/summaries/Summary of Safety and Clinical Performance / Periodic Safety Update Report etc.) documents and responses to Notified Bodies
- May write and edit manuscripts or abstracts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits and other projects requiring skill in medical communication.
- Collaborates with cross-functional team members daily, with the ability to provide solution orientated recommendations and to gather and analyze data related to the performance and safety of medical devices.
- Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
- Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.
- Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR.
- Post Market Surveillance activities (monthly literature review of our product)
- Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
- Seek out and engage regularly with peers, creating an environment of exchange and learning. Openly share successes and failures to promote the group’s collective learning. Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.
- Prepares literature for new products and revises existing literature.
- May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.
- Requires knowledge of product areas, current developments, and keeping abreast of current literature.
- Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
- Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards.
Required Knowledge and Experience
- B E or B.Tech in Mechanical/Biomedical Engineering
- Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience
- Understanding of CER, post-market surveillance processes and adverse event reporting.
- Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.Familiar with DMAIC or DMADV(DFSS) methodologies.
- Good verbal and written communication skills including plan / report development.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation.
- Knowledge of risk management principles and hazard analysis in the context of medical devices.
- An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
