Medtronic
Regulatory Affairs Strategic Planning Program Manager
Medtronic, Minneapolis, Minnesota, United States, 55400
We anticipate the application window for this opening will close on - 18 Dec 2024
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life As the Regulatory Affairs Strategic Planning Program Manager specializing in developing Globalization strategic implementation plan, you will be responsible for leading and managing multiple complex regulatory programs focused on expanding market access, maintaining access to current markets and ensuring compliance across international markets. Your role is critical in driving the execution of regulatory strategic plan, coordinating global submissions, and fostering cross-functional collaboration to achieve regulatory milestones efficiently. This position requires strong project management skills, regulatory expertise, and a strategic approach to navigating global regulatory landscapes.
This role requires a proactive individual with exceptional organizational, analytical, and interpersonal skills who can manage multiple projects and priorities simultaneously.
Location: Hybrid working arrangement from Lafayette, CO (preferred) / Minnesota / Mansfield, MA
Responsibilities
Develop long-range objectives and strategic plans for the corporation or major division by identifying internal and external strategic issues that could affect growth and profitability.
Scan the environment for business opportunities, maintain surveillance over the market, and perform financial analysis of acquisition candidates.
Develop and monitor profitability, productivity, and growth targets.
Prepare acquisition proposals, recommend financial and nonfinancial strategic objectives and alternatives, and implement and maintain strategic and operational plans.
Plan and coordinate business reviews, resource allocations, organization structures, and financial analysis.
Lead and manage regulatory strategic plan for ACM programs and projects focused on global market expansion, maintenance and compliance, ensuring alignment with business objectives and timelines.
Develop detailed strategic planning project plans, milestones, and timelines for regulatory activities across multiple international markets for ACM products, strategic alliance program, and distribution partnership.
Develop and implement a global regulatory strategic plan in collaboration with internal stakeholders, including Operations, Commercial teams, Regional Regulatory team, Regulatory design & Strategic Alliance team.
Drive alignment on regulatory requirements, submissions, and approvals to support product registration and commercialization goals.
Provide data-driven insights and recommendations to inform strategic decisions.
Collaborate closely with cross-functional teams to integrate regulatory considerations into product changes, renewal, expansion, and commercialization strategies.
Serve as a key liaison between regulatory affairs and other departments to ensure alignment on regulatory globalization execution and compliance activities.
Ensure compliance with global regulatory requirements and standards, monitoring changes and implementing necessary updates to strategic plan.
Track project progress, manage timelines, and report on project status.
Conduct risk assessments and identify potential regulatory risks and challenges associated with globalization strategies.
Stay informed about emerging regulatory trends, guidelines, and changes globally, providing strategic insights and recommendations to stakeholders.
Create and maintain regulatory strategic plans per class of trade.
Prepare and present regular updates, reports, and dashboards on regulatory program status, milestones, and key metrics to senior management and stakeholders.
Required Knowledge and Experience
Bachelor's degree with 5+ years of experience in regulatory affairs OR an advanced degree with 3+ years of experience in regulatory affairs.
7+ years of experience in medical device regulatory affairs with roles displaying increasing responsibility.
1+ year of experience in medical device regulatory affairs program management.
Strong project management skills with experience leading cross-functional teams and managing regulatory projects from inception to completion.
In-depth knowledge of global regulatory requirements (FDA, EMA, CFDA, PMDA, etc.) and regulatory affairs principles.
Excellent communication, organizational, and problem-solving skills with a proactive and results-oriented approach.
Ability to work effectively in a fast-paced environment, prioritize tasks, and manage multiple projects simultaneously.
Experience with regulatory submissions and approvals in international markets.
Proficiency in regulatory software applications, project management tools, and databases.
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.
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.
Salary ranges for U.S (excl. PR) locations (USD): $128,000.00 - $192,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
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 90,000+ 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.
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 law.
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At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life As the Regulatory Affairs Strategic Planning Program Manager specializing in developing Globalization strategic implementation plan, you will be responsible for leading and managing multiple complex regulatory programs focused on expanding market access, maintaining access to current markets and ensuring compliance across international markets. Your role is critical in driving the execution of regulatory strategic plan, coordinating global submissions, and fostering cross-functional collaboration to achieve regulatory milestones efficiently. This position requires strong project management skills, regulatory expertise, and a strategic approach to navigating global regulatory landscapes.
This role requires a proactive individual with exceptional organizational, analytical, and interpersonal skills who can manage multiple projects and priorities simultaneously.
Location: Hybrid working arrangement from Lafayette, CO (preferred) / Minnesota / Mansfield, MA
Responsibilities
Develop long-range objectives and strategic plans for the corporation or major division by identifying internal and external strategic issues that could affect growth and profitability.
Scan the environment for business opportunities, maintain surveillance over the market, and perform financial analysis of acquisition candidates.
Develop and monitor profitability, productivity, and growth targets.
Prepare acquisition proposals, recommend financial and nonfinancial strategic objectives and alternatives, and implement and maintain strategic and operational plans.
Plan and coordinate business reviews, resource allocations, organization structures, and financial analysis.
Lead and manage regulatory strategic plan for ACM programs and projects focused on global market expansion, maintenance and compliance, ensuring alignment with business objectives and timelines.
Develop detailed strategic planning project plans, milestones, and timelines for regulatory activities across multiple international markets for ACM products, strategic alliance program, and distribution partnership.
Develop and implement a global regulatory strategic plan in collaboration with internal stakeholders, including Operations, Commercial teams, Regional Regulatory team, Regulatory design & Strategic Alliance team.
Drive alignment on regulatory requirements, submissions, and approvals to support product registration and commercialization goals.
Provide data-driven insights and recommendations to inform strategic decisions.
Collaborate closely with cross-functional teams to integrate regulatory considerations into product changes, renewal, expansion, and commercialization strategies.
Serve as a key liaison between regulatory affairs and other departments to ensure alignment on regulatory globalization execution and compliance activities.
Ensure compliance with global regulatory requirements and standards, monitoring changes and implementing necessary updates to strategic plan.
Track project progress, manage timelines, and report on project status.
Conduct risk assessments and identify potential regulatory risks and challenges associated with globalization strategies.
Stay informed about emerging regulatory trends, guidelines, and changes globally, providing strategic insights and recommendations to stakeholders.
Create and maintain regulatory strategic plans per class of trade.
Prepare and present regular updates, reports, and dashboards on regulatory program status, milestones, and key metrics to senior management and stakeholders.
Required Knowledge and Experience
Bachelor's degree with 5+ years of experience in regulatory affairs OR an advanced degree with 3+ years of experience in regulatory affairs.
7+ years of experience in medical device regulatory affairs with roles displaying increasing responsibility.
1+ year of experience in medical device regulatory affairs program management.
Strong project management skills with experience leading cross-functional teams and managing regulatory projects from inception to completion.
In-depth knowledge of global regulatory requirements (FDA, EMA, CFDA, PMDA, etc.) and regulatory affairs principles.
Excellent communication, organizational, and problem-solving skills with a proactive and results-oriented approach.
Ability to work effectively in a fast-paced environment, prioritize tasks, and manage multiple projects simultaneously.
Experience with regulatory submissions and approvals in international markets.
Proficiency in regulatory software applications, project management tools, and databases.
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.
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.
Salary ranges for U.S (excl. PR) locations (USD): $128,000.00 - $192,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
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 90,000+ 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.
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 law.
#J-18808-Ljbffr