Spectranetics

Post Market Surveillance Manager

Spectranetics$134K — $186K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's degree in Mechanical Engineering, Industrial Engineering, or Science.
  • 5+ years of experience in Post Market Surveillance Operations or related fields.
  • Experience in leading teams in complex matrix organizations.
  • Familiarity with regulatory compliance and quality assurance processes.
  • Ability to perform required physical and cognitive job tasks.

Responsibilities

  • Oversee implementation of post-market surveillance processes to ensure regulatory compliance.
  • Enhance reporting systems for timely and accurate execution tracking.
  • Manage team talent, focusing on performance and career development.
  • Design training programs on regulatory compliance and quality management.
  • Conduct quality assurance assessments to maintain reporting accuracy.
  • Develop action plans for team performance and continuous improvement.
  • Lead medium to large scale process improvement initiatives.

Benefits

  • Generous paid time off (PTO).
  • 401k plan with up to a 7% match.
  • Health Savings Account (HSA) with company contributions.
  • Employee stock purchase plan.
  • Education reimbursement program.
Full Job Description
Job Title
Post Market Surveillance Manager

Job Description

Post Market Surveillance Manager

In this role you

Are responsible for overseeing post-market surveillance processes, enhancing reporting systems, managing team talent, designing training programs, conducting quality assurance assessments, leading process improvement efforts, applying statistical methods, implementing best practices, and investigating moderate product complaints to ensure regulatory compliance and drive continuous improvement.

Your role:


• Oversees the implementation of post market surveillance processes, ensures adherence to predefined parameters and standards, and ensures operations are conducted within established guidelines, contributing to efficiency and consistency in outcomes.
• Reviews reporting systems to track and analyze execution progress and enhances reporting tools and procedures to ensure timely and accurate reporting, enabling effective oversight of ongoing tasks and initiatives.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Designs comprehensive training programs on regulatory compliance, adverse event reporting, product complaint handling, risk management, recall management, quality management systems, documentation, and continuous improvement initiatives.
• Oversees meticulous quality assurance assessments on developed communication tools and ensures their accuracy in reporting and effectiveness in generating response plans to maintain regulatory compliance and address post-market surveillance concerns.
• Develops team management action plans, reviews progress, ensures timely completion and designs systematic tracking mechanisms to evaluate effectiveness, facilitating continuous improvement initiatives within the organization.
• Oversees medium to large scale process improvement efforts, coordinates analysis, design, and implementation phases to enhance operational efficiency and align with organizational objectives.


You're the right fit if:

  • Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • 5+ years of experience with Bachelor's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
  • 5+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for thisposition.

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 company27s facilities. Field roles are most effectively done outside of the company27s main facilities, generally at the customers27 or suppliers27 locations.

This is an office role.

Philips Transparency Details

The pay range for this position in Cambridge, MA is $134,000 to $186,000 Annually.

The pay range for this position in Bothell, WA is $134,000 to $186,000 Annually.

The pay range for this position in Reedsville, PA is $120,000 to $170,000 Annually.

The pay range for this position in Plymouth, MN is $126,000 to $175,000 Annually.

The pay range for this position in San Diego, CA is $134,000 to $186,000 Annually.

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 .

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 Cambridge MA, Bothell WA, Reedsville PA, Plymouth MN, San Diego CA.

#LI-PHI

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

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