Senior Clinical Development Scientist / Medical Safety Manager

Regulatory Toolkit; Bothell (WA); Vor Ort; USD 149.000 - 237.000; Vollzeit

Zusammenfassung

Regulatory Jobs is seeking an experienced Senior Clinical Development Scientist/Medical Safety Manager to lead clinical evidence strategy and safety assessments for medical devices. The role partners with investigators and cross-functional teams to advance product development, regulatory documentation, and risk-benefit analyses.

You will analyze trial data, evaluate safety information from multiple sources, and support safety surveillance and regulatory submissions across the product lifecycle.

Qualifikationen

• 7+ years of experience in the medical device industry or similar performing medical safety risk assessments and/or conducting clinical research on medical devices.
• Experience in the oral healthcare or dentistry space highly preferred.
• Doctoral degree in Dentistry or Dental Hygiene strongly preferred, OR a PhD in scientific research in the medical devices space.
• Office-based role with in-person presence required.

Aufgaben

• Support clinical evidence strategy, medical safety activities, and regulatory documentation across the product lifecycle.
• Analyze clinical trial protocols and studies to support development with data integrity and scientific rigor.
• Evaluate safety information from studies, post-market data, literature reviews, and real-world data to identify safety risks.
• Collaborate with cross-functional teams on New Product Introduction projects and safety surveillance.
• Translate clinical and safety findings into clear information for internal stakeholders and external investigators.

Kenntnisse

Clinical development strategy

Medical safety risk assessment

Cross-functional collaboration

Scientific communication

Regulatory understanding (ISO/IEC)

Ausbildung

Doctoral degree in Dentistry or Dental Hygiene / PhD in medical devices

Tools

GCP knowledge

Regulatory documentation standards

Jobbeschreibung

Job Title

Senior Clinical Development Scientist / Medical Safety Manager

Job Description

Senior Clinical Development Scientist/Medical Safety Manager

The Senior Clinical Development Scientist/Medical Safety Manager for Oral Healthcare supports clinical evidence strategy and medical safety throughout the product lifecycle by evaluating clinical and post-market data, maintaining scientific rigor, and identifying potential safety risks. The role partners with cross-functional teams, investigators, and Key Opinion Leaders to advance new product development, regulatory documentation, risk-benefit assessments, and scientific communications.

Your role:

• Support clinical evidence generation, clinical development strategy, and medical safety activities across the product lifecycle. Contribute to patient safety, regulatory compliance, and evidence-based decision-making.
• Analyze clinical trial protocols and clinical studies to support clinical development. Ensure clinical data integrity, scientific rigor, and reliable interpretation of study results.
• Evaluate safety information from clinical studies, Post-Market Surveillance, literature reviews, real-world data, and other safety surveillance sources. Identify potential safety risks and support ongoing safety monitoring.
• Collaborate with multidisciplinary teams on New Product Introduction projects, post-market initiatives, risk-benefit analyses, safety surveillance, and regulatory documentation. Provide clinical and medical safety input throughout the product lifecycle.
• Support evidence dissemination and scientific communications with internal stakeholders, external investigators, Key Opinion Leaders, and cross-functional partners. Translate clinical and safety findings into clear information that supports alignment and informed decisions.

You're the right fit if:

• You’ve acquired 7+ years of experience in the medical device industry or similar performing medical safety risk assessments and/or conducting clinical research on medical devices. Experience in the oral healthcare or dentistry space highly preferred.
• Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses and how to conduct them in a medical device environment. You also have a strong understanding of clinical research as it relates to the medical device industry and the relevant standards that accompany it.
• You have a doctoral degree in Dentistry or Dental Hygienist background strongly preferred, OR a PhD in scientific research in the medical devices space required.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your clinical expertise and knowledge of standard of care and medical device standards.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Bothell, WA is $149,000 to $237,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.