MED Medtronic Inc
Principal Regulatory Affairs Specialist, US Regulatory Policy
MED Medtronic Inc, Washington, District of Columbia, us, 20022
Principal Regulatory Affairs Specialist, US Regulatory PolicyAt 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
LOCATION: The person in this role may work remotely within the US or onsite at a US-based Medtronic facility. Preference for the person to work EST hours.
The Medtronic Global Regulatory Affairs team is looking for a highly motivated and skilled individual to join our Clinical Research, Medical Science, and Regulatory Affairs Organization. In this role, you will be a key contributor and advocate, with a primary responsibility of shaping U.S. medical device regulatory policy.
Your success in this role is reliant on your ability and willingness to operate in a fast-paced, multi-tasking, geographically dispersed team environment. You will be responsible for monitoring and influencing U.S. regulatory policies related to medical devices and advocating for Medtronic's interests in relation to US Food and Drug Administration (FDA) policy.
Your expertise and guidance will play a crucial role in shaping the regulatory landscape for Medtronic's medical devices, ultimately enhancing patient access to innovative healthcare solutions.
A DAY IN THE LIFE
Works with regional SMEs to develop and execute U.S. regulatory advocacy strategies and action plans, including identifying opportunities for advocacy/educational opportunities with regulators.
May direct interaction with regulatory agencies on defined matters and engage with industry associations, including AdvaMed, and other stakeholders to influence U.S. regulatory policy development.
Keeps abreast of developing U.S. regulatory guidelines, regulations, and policies related to medical devices, provides analysis of impact to Medtronic, and communicates relevant updates to internal stakeholders.
Monitors industry trends and emerging U.S. regulatory issues impacting Medtronic’s business and regulatory environment.
Collaborates with cross-functional teams to identify U.S. regulatory challenges and develop and implement advocacy strategies for addressing them.
Leads on commenting for external documents and participates on external working groups, as needed.
Supports other team members in advancing global policy efforts, including commenting on key documents.
Leads work to develop talking points that can be utilized in U.S. regulatory advocacy work, and works with communications support to develop presentations for advocacy to regulators.
Works with project manager to maintain and update the Global Regulatory Policy SharePoint, including providing summaries of key policy updates, identifying commenting opportunities, and maintaining advocacy trackers to support U.S. regulatory advocacy efforts.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the 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.
Monitors and improves tracking/control systems.
Recommends strategies for earliest possible approvals of clinical trials applications.
MUST HAVE
Bachelor’s degree plus 7+ years of related experience within the medical device industry or a regulatory agency (or 5+ years with an advanced degree).
NICE TO HAVE
Demonstrable understanding of U.S. FDA regulatory requirements and policy.
Regulatory experience within the medical device industry or a regulatory agency, such as the FDA.
Experience in advocacy related to healthcare policy and regulations.
Ability to analyze complex information, identify key issues, and develop strategic approaches.
Ability to synthesize and present on complex technical topics.
Strong interpersonal, oral, presentation, and written communication skills.
Flexible work hours to accommodate global stakeholders.
Demonstrated ability to work successfully in complex business and project areas.
Ability to deal with ambiguity and changing environments, to learn quickly and teach others; flexible and able to adapt to shifting priorities.
Strong research and analytical skills.
Experience with technical regulatory topics and strong working knowledge of device regulatory requirements.
Innovative and strategic thinker.
Self-starter.
Global mindset.
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 PackageA 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): $114,400.00 - $171,600.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
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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A Day in the Life
LOCATION: The person in this role may work remotely within the US or onsite at a US-based Medtronic facility. Preference for the person to work EST hours.
The Medtronic Global Regulatory Affairs team is looking for a highly motivated and skilled individual to join our Clinical Research, Medical Science, and Regulatory Affairs Organization. In this role, you will be a key contributor and advocate, with a primary responsibility of shaping U.S. medical device regulatory policy.
Your success in this role is reliant on your ability and willingness to operate in a fast-paced, multi-tasking, geographically dispersed team environment. You will be responsible for monitoring and influencing U.S. regulatory policies related to medical devices and advocating for Medtronic's interests in relation to US Food and Drug Administration (FDA) policy.
Your expertise and guidance will play a crucial role in shaping the regulatory landscape for Medtronic's medical devices, ultimately enhancing patient access to innovative healthcare solutions.
A DAY IN THE LIFE
Works with regional SMEs to develop and execute U.S. regulatory advocacy strategies and action plans, including identifying opportunities for advocacy/educational opportunities with regulators.
May direct interaction with regulatory agencies on defined matters and engage with industry associations, including AdvaMed, and other stakeholders to influence U.S. regulatory policy development.
Keeps abreast of developing U.S. regulatory guidelines, regulations, and policies related to medical devices, provides analysis of impact to Medtronic, and communicates relevant updates to internal stakeholders.
Monitors industry trends and emerging U.S. regulatory issues impacting Medtronic’s business and regulatory environment.
Collaborates with cross-functional teams to identify U.S. regulatory challenges and develop and implement advocacy strategies for addressing them.
Leads on commenting for external documents and participates on external working groups, as needed.
Supports other team members in advancing global policy efforts, including commenting on key documents.
Leads work to develop talking points that can be utilized in U.S. regulatory advocacy work, and works with communications support to develop presentations for advocacy to regulators.
Works with project manager to maintain and update the Global Regulatory Policy SharePoint, including providing summaries of key policy updates, identifying commenting opportunities, and maintaining advocacy trackers to support U.S. regulatory advocacy efforts.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the 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.
Monitors and improves tracking/control systems.
Recommends strategies for earliest possible approvals of clinical trials applications.
MUST HAVE
Bachelor’s degree plus 7+ years of related experience within the medical device industry or a regulatory agency (or 5+ years with an advanced degree).
NICE TO HAVE
Demonstrable understanding of U.S. FDA regulatory requirements and policy.
Regulatory experience within the medical device industry or a regulatory agency, such as the FDA.
Experience in advocacy related to healthcare policy and regulations.
Ability to analyze complex information, identify key issues, and develop strategic approaches.
Ability to synthesize and present on complex technical topics.
Strong interpersonal, oral, presentation, and written communication skills.
Flexible work hours to accommodate global stakeholders.
Demonstrated ability to work successfully in complex business and project areas.
Ability to deal with ambiguity and changing environments, to learn quickly and teach others; flexible and able to adapt to shifting priorities.
Strong research and analytical skills.
Experience with technical regulatory topics and strong working knowledge of device regulatory requirements.
Innovative and strategic thinker.
Self-starter.
Global mindset.
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 PackageA 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): $114,400.00 - $171,600.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
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