Spectranetics

Product Performance / Post Market Surveillance

Spectranetics$180K — $252K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or equivalent.
  • 8+ years of experience with a Bachelor's OR 6+ years with a Master's in relevant fields.
  • Prefer 7+ years of experience leading teams in complex matrix organizations.
  • Demonstrated experience in Post Market Surveillance Operations, Medical Device, Quality Assurance, and related areas.
  • Strong understanding of regulatory compliance and quality management systems.

Responsibilities

  • Champion operational excellence in post-market surveillance processes.
  • Facilitate reporting audits to enhance reporting systems and procedures.
  • Lead talent management initiatives including succession planning and performance management.
  • Review and refine training programs on regulatory and quality management topics.
  • Engage with regulators and participate in strategic discussions on quality.
  • Build relationships with Quality leaders across various Philips Business Clusters.
  • Interpret emerging regulations and recommend adjustments to quality systems.

Benefits

  • Generous paid time off (PTO).
  • 401(k) plan with up to 7% company match.
  • Health Savings Account (HSA) with company contributions.
  • Stock purchase plan available to employees.
  • Education reimbursement for continuous learning.
Full Job Description
Job Title
Product Performance / Post Market Surveillance

Job Description

Product Performance/Post Market Surveillance

In this role you

Are responsible for championing operational excellence in post market surveillance processes, overseeing adherence to predefined parameters and standards, facilitating reporting audits, leading talent management and training programs, strategizing management action items and developing risk mitigation plans.

Your role:

• Facilitates reporting audits to ensure enhanced reporting systems, monitors implementation of enhanced procedures, analyzes collected data for improvement opportunities, and recommends adjustments for enhanced efficiency and accuracy.
• Leads succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.
• Reviews and refines comprehensive training programs on regulatory compliance, adverse event reporting, product complaint handling, risk management, recall management, quality management systems, documentation, and continuous improvement initiatives.
• Engages with regulators, actively participates in direct dialogue and negotiations on strategic topics related to post-market quality.
• Builds and fosters strong relationships with Quality leaders across Philips' Business Clusters, Integrated Supply Chain, Central Quality, Regional Regulatory and Compliance, and other functional areas.
• Provides interpretation of emerging regulations and recommend necessary adjustments to quality systems, policies, or procedures in collaboration with Central PMS Organization.

You're the right fit if:

  • Bachelor's / Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
  • 8+ years of experience with Bachelor's OR 6+ years of experience with Master's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
  • Prefer 7+ 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 $180,600 to $252,000 Annually.

The pay range for this position in Bothell, WA is $180,600 to $252,000 Annually.

The pay range for this position in Reedsville, PA is $180,600 to $252,000 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.

#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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