Sr Regulatory Affairs Program Manager

Medtronic
Posted on

Type

Executive / senior industry position

Senior Regulatory Affairs Program Manager - Renal Care Solutions

The Senior Regulatory Affairs Program Manager will lead the regulatory activities for novel and complex innovative combination product for dialysis therapies. Will be the regulatory representative on cross-functional teams and provide regulatory advice to Product Development and Clinical Teams on regulatory matters relating to the development and life cycle management of combination/drug product. Will drive the development of innovative regulatory strategies including strategies for novel combination product and provide strategic regulatory guidance to enable global implementation.  Prepare and lead regulatory meetings with the regulatory agencies.  Author and coordinate preparation of regulatory filings (such as ANDA, NDA, IND and DMF, PMA, amendments, supplements, annual reports and Periodic Adverse Event Reports, IDEs, 510(k)s, technical files, etc). 

 

• Develop and execute regulatory strategies and processes for both new and existing combination products/drug products. • Lead the preparation and discussions for regulatory body meetings.  Interact and effectively negotiate with regulatory authorities.• Develop and communicate timelines for the regulatory meetings, submissions and for the delivery of supporting documentation. Must work closely with all functional areas to obtain on time delivery of information.• Lead the development and integration of regulatory processes for combination product/drug product relating to development, commercialization interfaces and life cycle management. • Work closely with global teams (research and development (R&D), quality, operations, supply chain, and marketing early in the development phase to provide regulatory guidance and interpretation/application of regulatory requirements. • Anticipate the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and advise the teams as needed.• Review scientific information and design documentation to ensure the data is complete, sound, logical, and supports the program goals. Must be able to work with authors to ensure supporting information is high quality, clearly and logically written, in order to ensure it is submission ready.• Provide guidance on the creation of labeling as well as review and approve labeling, promotional and advertising collateral as applicable to ensure compliance to industry standards and regulations. • Support post marketing surveillance programs. • Author and coordinate the preparation of combination product/drug product filings. Maintain regulatory files and other submission documentation as well as tracking of all regulatory correspondence. • Stay abreast of applicable regulations and guidance’s as well as new and changing regulations.  Interprets regulations and ensures regulatory compliance.  Exercises good judgment within company policy and regulatory authority regulations. Inform project teams of new information, along with its possible impact to the project, as appropriate.• Advise on and support medical device/software/combination/drug product regulatory compliance initiatives.• Support development of design control documentation and quality systems for combination product or drug product.• Mentor/lead junior team members.

 

Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.  Let’s work together to address universal healthcare needs and improve patients’ lives.  Help us shape the future.

The Renal Care Solutions Business, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience advancing renal care through innovative design.  We strive to improve outcomes, access, and quality of life for patients affected by renal disease by offering a range of products, services and solutions—to take renal care globally Further Together.  

This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $30.5Billion company with 90,000+ employees in more than 160 countries.

 

Must Have: Minimum Requirements (Must be evident on the resume)• Bachelor’s degree • 7+ years of experience in either pharmaceutical or pharmaceutical & medical device combination product related regulatory affairs, preferably both. Must quickly become effective in both disciplines. â€˘ Master’s degree is preferred; Ph. D. is highly preferred• Thorough understanding of drug development process and FDA drug regulations is required.• Preparation and review of CMC sections of INDs, NDAs, ANDAs, and MAAs in Common Technical Document format.• Proven experience with navigating combination product regulatory filings including request for designations.• Experience interacting with FDA OCP, CDER and CDRH and European Medicines Agency.• Experience with water purification systems resulting in sterile water.• Preparation of sterilization process validation section for regulatory filings.• Experience reviewing validation protocols for laboratory equipment, process equipment, and process validation.• Knowledge of medical devices (including knowledge of electronic/software-based devices).• Excellent written and verbal communications skills.• Good analytical thinking skills.• Proven ability to lead and work effectively in cross-functional teams.• Ability to work in matrix teams.• Strong organization and time management skills.• Demonstrated ability to influence based on experience, facts and data.• Highly motivated and results-oriented leader. • Project-management skills and experience.• Detail-oriented.• Submission-related word processing skills.• Ability to travel internationally up to 15%.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.   Physical 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 Position 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.• The employee is required to be independently mobile• The employee must be able to travel independently to various Medtronic buildings/sites.• The employee is required to interact with a computer, and communicate with co-workers• The employee is required to travel by car and by airplane (<15%), including possible International travel This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Medtronic is a $30.5 Billion company with 90,000+ employees in more than 160 countries.  The Renal Care Solutions Business, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience advancing renal care through innovative design.  We strive to improve outcomes, access, and quality of life for patients affected by renal disease by offering a range of products, services and solutions—to take renal care globally Further Together.    ABOUT MEDTRONIC:Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. EEO STATEMENT: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. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees  DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. 

 

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Posted on

Type

Executive / senior industry position

Minneapolis%2C%20United%20States

Minneapolis , United States