Location: North America, USA, Minneapolis
Job Function: Reg Affairs Quality Assurance
Smiths Medical is currently hiring aCER Specialist IIin Minneapolis, MN.
TheCER Specialist IIwill be responsible for writing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for Smiths Medical products sold in geographies conforming to CE Mark regulations. A number of personnel from different departments will be contributing documentation necessary for completion of a CEP and a CER. The Specialist brings these individuals together and directs them regarding the information needed for CEPs and CERs. The Specialist has experience and understanding in clinical research and regulatory guidelines.
Smiths Medical has a positive impact on someone's life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline.
Duties & Responsibilities
Conduct literature searches on Smiths products and product families, and identified competitor products.
Review of the published literature to identify articles germane to the safety and performance of Smiths products.
Assist in the continuous improvement of Clinical Evaluation procedures, forms and software tools. Streamline CEP/CER process for NPI projects.
Lead the development of CEPs and CERs by bringing together various stakeholders to identify relevant documentation needed for the content of CERs. Completed drafts of CEPs and CERs are then circulated for comment from these stakeholders, and a meeting held to review the comments from stakeholders and content of the CERs.
Collaborate with stakeholders on cross-functional teams to provide input on clinical claims, risk management deliverables, standards compliance deliverables, product labeling (including instructions for use), complaints and sales history, clinical research, and clinical literature evidence.
Collaborate with Regulatory Affairs Specialist regarding needs for identified regulatory strategy and required submissions, as appropriate.
Engages with other Clinical related departments (e.g. CHEM, Clinical Education, Medical)-and other activities, as appropriate. Collaborate on development of tools that can be utilized across Smiths Medical.
Complete Regulatory Affairs documentation as it relates to CERs, or as needed under Regulatory Affairs supervision.
Assist Product Registration Specialist with needed CER documentation and publications referenced in CERs.
Complete, as requested, duties assigned by Manager or higher levels of management as related to CERs or other GQR required duties.
Work with more senior level Clinical Evaluation Specialist, as needed, to complete CEPs. CERs and related documentation.
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Diversity & Inclusion
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.
University Degree (BA degree) required.
Minimum of a Bachelor's degree required with preference in a science, biological, engineering or medical science area (A post graduate degree in these fields is preferred).
Experience in the medical device industry or pharmaceutical industry in clinical or regulatory roles.
Solid understanding of scientific/clinical research methodology.
In-depth knowledge of regulatory process (e.g., CE Marking, IDE, PMA, 510(k), post-market/post-approval), GCP procedures, and legal compliance for pharmaceutical and/or medical device industry.
Demonstrated writing capability and critique of clinical and regulatory documentation.
Program/project management skills for effective project execution and management.
Excellent communication and interpersonal skills, able to establish and maintain effective communications with colleagues, customers, and clinical study site personnel.
Facility with general writing and presentation software, clinical trials management software, and business platform software.
Education requirements can be obtained through an educational institution or gained through equivalent work experience.
Salary & Benefits
In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!
At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.