A growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency.

With customers in all over the world, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service.

• Authoring Clinical documentation mainly the Clinical Evaluation Plans and Reports (CEP/CER) including clinical section of regulatory authority requests.
• Acquire or possess in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
• Participates in and/or performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends.
• Providing product guidance and expertise to conduct literature searches on products/product families.
• Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
• Critically appraise scientific literature and write clinical summaries for products.
• Managing regulatory/clinical documentation timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
• Will support broader Clinical/Scientific Affairs activities such as Regulatory submissions/responses.
• Interacting with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation plans/reports for new products requiring CE Mark.
• Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities.
• Perform periodic reviews of risk documention and product labeling; ensure appropriate updates are implemented.
• Provide clinical perspective and support to guide new product development for CE Mark purposes. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.
• May author routine Clinical Study Progress Reports.
• Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines).

• Advanced education/degree in life sciences/healthcare or equivalent work experience is required.
• Fluent English (oral and written).
• 4 years' experience in clinical research with proven proficiency in global development.
• Advanced knowledge of and repeat experience in global registration of drugs (complex submissions).
• Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Solid leadership talent and negotiation skills.
• Team management experience with cross-functional and global responsibilities.

Great company, awesome policies, very open and transparent leadership.

Strong leadership, friendly coworkers, good pay and benefits, opportunities to develop and advance