Senior Program Manager, Post-Market Surveillance
Senior Program Manager, Post-Market Surveillance
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$ 168800 - 253200
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Medtronic is seeking a highly skilled and innovative Senior Program Manager Post-Market Surveillance (PMS) to join our PMS Center of Expertise. The successful candidate will play a critical role in driving excellence in PMS strategies and practices ensuring effective PMS processes dedicated to patient safety and global regulatory compliance and establishing Medtronic as a leader in state-of-the-art post-market surveillance.With a Put Patients First mindset this position demands an action-oriented strategic thinker who is also grounded in practical collaborative approaches to delivering impactful results. Reporting to the leader of Risk Management and PMS Centers of Expertise the PMS Expert will lead initiatives to improve the PMS processes patient safety and organizational success while fostering effective cross-functional partnerships.
This is an on-site position that requires candidates to work in the Mounds View MN Lafayette CO Boston MA Memphis TN or Santa Rosa CA office 4-days per week minimum.
Responsibilities may include the following and other duties may be assigned.
PMS Expertise and Leadership
Assess the current Post-Market Surveillance (PMS) processes and develop proactive safety/compliance driven strategies.
Monitor and analyze post-market surveillance data metrics and KPIs (e.g. complaints adverse events external signals) to identify risks trends and opportunities for process and product improvement.
Advise Operating Units and enterprise functions regarding post-market surveillance processes and activities in collaboration with Quality Regulatory Affairs and Medical Safety teams.
Support internal and external audits related to PMS activities serving as the subject matter expert (SME) and ensuring alignment with global regulatory standards.
Risk Management Partnership
Identify opportunities to improve seamless integration of PMS with risk management frameworks including methodologies to ensure the life-cycle processes activities and documentation alignment and integration).
Collaborate with Risk Management Center of Expertise (COE) experts and cross-functional teams to proactively assess and mitigate risks associated with Medtronic products ensuring patient-centric decision-making.
Innovation and Continuous Improvement
Drive initiatives to position Medtronic as a best-in-class organization in PMS by identifying and implementing innovative tools technologies (e.g. Digital AI/ML) and methodologies.
Proactively address gaps in systems and processes ensuring alignment with evolving regulatory expectations and industry standards.
Establish and optimize meaningful KPIs to measure PMS effectiveness performance and efficiency ensuring actionable insights and continuous improvement.
Maintain and continuously improve quality system procedures related to PMS to meet evolving regulatory requirements and industry best practices
Cross-Functional Collaboration
Foster strong partnerships across internal teams including OU teams Quality Regulatory R&D and Medical Safety to ensure productive collaboration and alignment on PMS activities.
Provide strategic guidance and leadership to support PMS-related initiatives across multiple business units driving safety and compliance-oriented solutions.
Represent the PMS COE in cross-functional and executive meetings ensuring alignment with organizational goals and regulatory priorities.
Promote a culture of collaboration accountability and excellence
Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident on your resume.
Bachelors degree
Minimum 7 years of experience in post-market surveillance risk management CAPA FCA (recalls) and complaints handling within the medical device industry or other regulated health care industries.
OR advanced degree with a minimum of 5 years of experience in post-market surveillance risk management CAPA FCA (recalls) and complaints handling within the medical device industry or other regulated health care industries.
Nice to Have:
Bachelors degree in Engineering Life Sciences or related STEM field.
Advanced degree preferred (e.g. MS or PhD) in STEM fields.
Proven track record of establishing and improving PMS processes and systems with a focus on patient safety.
Experience working across multiple business units and geographies.
Strong understanding of EU MDR FDA and other global regulatory requirements.
Strong working knowledge of global regulations (e.g. FDAs 21 CFR 820 EU MDR and other global regulations) and international standards (e.g. ISO 13485 and ISO 14971)
Exceptional leadership communication analytical influencing and interpersonal skills.
Strategic thinker with the ability to balance visionary goals with realistic practical execution.
Action-driven and focused on delivering measurable results.
Adept at building cross-functional partnerships and influencing stakeholders effectively.
Experience leading complex projects/programs
Experience with SPC CAPA NCMR PDP processes
Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously
Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization
PMP Certification
Manufacturing Experience
Green Belt Six Sigma/DRM Training/Certification
Demonstrated working knowledge of process validation statistical methods risk management
#LI-MDT
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
Employment Type
Full-Time
