Sr. Regulatory Affairs Program Manager
Sr. Regulatory Affairs Program Manager
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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
The Senior Regulatory Program Manager will manage implementation regulatory activities of Robotics Surgical Technologies (RST) portfolio.The mission of Global Regulatory Affairs is to influence the regulatory environment develop innovative strategies for regulatory approval and post-introduction requirements and anticipate and respond to changing requirements in order to benefit the patients we serve.
Location: Strong preference to have a candidate work from Lafayette CO Boston MA North Haven CT or Mounds View MN. Will consider candidates to work from another MDT facility in the U.S. or work remotely within the U.S.
Travel: 25%
Responsibilities may include the following and other duties may be assigned:
Manages the development and execution of Robotic Surgical Technologies (RST) regulatory program strategies to enable business strategy and performance
Manages partnerships with RST stakeholders for R&D QA Operations functional COEs regional Regulatory and Quality and the Medtronic Enterprise
Focuses on tactical operational and strategic activities for RST programs with broad or ongoing impact
Problems and issues faced are complex difficult and undefined and require managing detailed information gathering analysis and investigation to understand the problem. Problems typically impact multiple major job areas businesses or functions within the program
Monitors and improves tracking / control systems
Keeps abreast of US EU and global procedures and changes and assures implementation
May support interaction with regulatory agencies on defined matters
Recommends strategies for earliest possible certifications
Through the implementation of productivity tools maintain and track progress and produce (or oversee the production) of applicable reports
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
Leads or compiles all materials required in submissions license renewal and annual registrations.
Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
Oversees and/or conducts comprehensive reviews of promotional materials
Must Have: Minimum Requirements
Bachelors degree with 7 years of medical device regulatory affairs experience
OR
An advanced degree with 5 years of medical device regulatory affairs experience
Nice to Have:
7 years of experience in medical device regulatory affairs with roles displaying added responsibility
Degree in Engineering
Experience with 510(k) DeNovo and/or PMA regulatory submissions for complex and connected systems (e.g. capital equipment software instruments and accessories or other devices of similar complexity) program management and implementation
Experience working with US FDA EU Notified Bodies and/or other regulators during the review of technical documentation
Demonstrated ability for strategic thinking project planning and project management
Experience driving initiatives and change management
Strong influence management skills. Demonstrated ability to work cooperatively at all levels in an organization to build and maintain relationships required to accomplish program goals
Ability to balance priorities work independently or collaboratively to determine and develop solutions
Exceptional facilitation analytical planning organization and time management skills to effectively execute project plans
Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
PROGRAM MANAGEMENT CAREER STREAM:Program Managers and Directors focus on tactical operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility managing program/team performance communicating project and operational developments planning prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.
DIFFERENTIATING FACTORS
Autonomy:Manages one or more medium-scale established programs with generally-defined program plans and delivery methodologies.
Is accountable for overall program process performance and customer satisfaction.
Organizational Impact:Participates in establishing program objectives timelines milestones and budgets .
Develops new policies and procedures that affect program management.
Typically has budget accountability for one or more programs.
Program decisions are generally recommended to higher level management.
Innovation and Complexity:Problems and issues faced are difficult and undefined and require detailed information gathering analysis and investigation to understand the problem.
Problems typically impact multiple workstreams departments or specialties .
Enhances programs management processes to improve program.
Communication and Influence:Communicates and leads meetings with internal and external customers and vendors conducts briefings to higher level management team.
Influences across functions and businesses while balancing divergent objectives to gain cooperation of other parties on program objectives and execution plans .
Leadership and Talent Management:Leads directs and reviews the work of a team of managers experienced professionals and/or vendors who exercise latitude and independence in their assignments.
Establishes daily tasks necessary for successful program execution.
Not directly responsible for hire or fire decisions and people management.
Required Knowledge and Experience:Requires broad management knowledge and experience to lead project teams in one department.
Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 7 years of relevant experience or advanced degree with a minimum of 5 years relevant experience.
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
