Job Description:

Clinical Evaluation and Post Market Surveillance Specialist

Location: North America, USA, Minneapolis
Ref: MEDNA01157
Division: Medical
Job Function: Reg Affairs Quality Assurance

Job Description

Smiths Medical is currently hiring aClinical Evaluation & Post Market Surveillance Specialistin Minneapolis, MN.

TheClinical Evaluation & Post Market Surveillance Specialistwill be responsible for writing portions of Clinical Evaluation Reports (CERs) and Post Market Surveillance Reports for Smiths Medical products, as well as managing the Post Market Clinical Follow-Up Review Process. The Specialist relies on internal and external documentation to complete these documents. The Specialist is responsible for convening representatives together to form multi-disciplinary teams and leads the team through to document approval.

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

• Assist with summarizing literature searches on Smiths products and product families, and identified predicate and competitor products, and reviewing the published literature to identify articles germane to the safety and performance of Smiths products.


• Complete evaluation of competitor products within vigilance databases held by multiple competent authorities, drawing conclusions germane to the complaint trends experienced by competitor products.


• Coordinate PMCF Reviews and assist with pre-review activities, summarizing conclusions, and forwarding them to stakeholders for evaluation and review. Completed drafts of PMCF Reviews, Plans, and Reports are then circulated for comment from these stakeholders, and a meeting held to review the comments from stakeholders and content of the CERs.


• Post Market Surveillance documentation as it relates to PMS Reports.


• Support more senior level Clinical Evaluation Specialist as needed to complete CERs and related documentation.


• Complete, as requested, duties assigned by Manager of Clinical Evaluation and Post Market Surveillance Reporting relating to PMCF. CER, and PMS Support.


• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.


• 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).

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.

The Individual

• University Degree (BA degree) required.


• Degree in biological or medical science is preferred (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.


• 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!

About Smiths

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.

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