Spectranetics

Medical Safety Manager Complaints Handling

Spectranetics$133K — $237K *
US-AnywhereRemote in United States
Healthcare
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 10+ years in Medical Safety/Medical Affairs Risk Management in Medical Devices
  • 4+ years post-market experience
  • Bachelor's/Master's in medical science, Nursing, Respiratory Therapy, or equivalent
  • Certified Professional in Patient Safety (CPPS) preferred
  • Strong communication skills with cross-functional teamwork experience

Responsibilities

  • Conduct clinical assessments on injury or death complaints for Philips products
  • Provide input for Issue Impact Assessments and Health Hazard Evaluations
  • Serve as a subject matter expert in post-market surveillance and ensure regulatory compliance
  • Drive continuous improvement initiatives in complaint handling processes
  • Communicate clinical insights effectively across global teams
  • Support recruitment and development of team talent
  • Participate in governance meetings for consistent decision-making

Benefits

  • Generous paid time off (PTO)
  • 401k plan with up to 7% company match
  • Health Savings Account (HSA) with company contributions
  • Employee stock purchase plan
  • Education reimbursement opportunities
  • Comprehensive Philips Total Rewards benefits program
Full Job Description
Job Title
Medical Safety Manager Complaints Handling

Job Description

Medical Safety Manager, Complaints Handling

The Medical Safety Manager, Complaints Handling, performs clinical assessments on complaints related to harm to assist in regulatory reportability determination and serves as the primary clinical liaison between Post Market Surveillance and Medical Safety, facilitating escalations as necessary. This role makes harm severity and IMDRF coding determinations and drives continuous improvement initiatives in post market surveillance activities, collaborating with technical experts to resolve issues and support corrective actions.

Your role:
  • Accountable for preliminary clinical assessments for issues alleging injury or death for Philips products as well as providing input for Issue Impact Assessments/HHED.
  • Performs clinical assessments for Philips products involving injury or death allegations, contribute to Issue Impact Assessments/HHED, and ensure prompt escalation and resolution of complex complaints.
  • Participate in governance meetings, provide clinical insights for consistent decision-making, and serve as a subject matter expert in post-market surveillance activities to ensure regulatory compliance and patient safety.
  • Continuously evaluate and improve post-market surveillance processes, collaborate with global complaint handling and correction teams, and drive solutions to address gaps and enhance efficiency.
  • Communicate post-market clinical insights across businesses, markets, functions, and suppliers to support continuous improvement in complaint handling and corrections and removals for Philips products.
  • Support compliance with global regulations and internal quality standards, implement and refine operational processes for clinical input, and contribute to recruiting, developing, and coaching talent within the team.

You're the right fit if:
  • You've acquired 10+ years of experience in Medical Safety/Medical Affairs Risk Management in the Medical Device industry. Prior hands-on bedside/clinical experience required. 4+ years of post-market experience required.
  • Your skills include familiarity with CFR, EUMDR, ISO standards, etc. Experience with Issue Impact Assessments, Health Hazard Evaluations, and Risk Benefit Analyses is preferred but not required.
  • You have a bachelor's/master's degree in medical science, Nursing, Respiratory Therapy or equivalent. Certified Professional in Patient Safety (CPPS) preferred.
  • 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 work well cross functionally, and in a complex global working environment.


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 a field-based role.

The pay range for this position in AL, AZ, AR, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MI, MS, MO, MN, NC, ND, NE, NH, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY is $133,000 to $212,000.

The pay range for this position in AK, DE, HI, MD, MN, and RI is $140,000 to $223,000.

The pay range for this position in CA, CT, DC, MA, NJ, NY, or 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 posted locations.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

About Spectranetics

Spectranetics is a medical device company that develops, manufactures, and markets single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products include laser atherectomy systems, thrombectomy systems, and lead management accessories. Spectranetics was founded in 1984 and is headquartered in Colorado Springs, Colorado. In 2017, the company was acquired by Royal Philips for $2.2 billion.
Learn more about Spectranetics
Size
900 employees
Industry
Founded
1980

Similar Jobs

More Jobs at Spectranetics

More Healthcare Jobs

Find similar Medical Safety Manager Complaints Handling jobs: