Director Regulatory Affairs

Medtronic
Posted on

Type

Executive / senior industry position

Careers That Change LivesTogether, 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. Position DescriptionThe Director of Regulatory Affairs will report directly to the VP of Regulatory Affairs, RGI.  This position oversees the global registration and pre-market submissions for new/modified products Patient Monitoring (PM), one of the three divisions of RGI. Reviews and evaluates submissions for accuracy and completeness.  Coordinates and maintains reporting schedules for products.  Ensures clinical trial protocols are properly designed to support regulatory objectives. Interacts with global regulatory personnel in order to expedite approval of pending registrations.  Interacts with regulatory agency personnel worldwide in order to expedite approval of pending applications.  Ensures compliance with FDA and global regulations and interpretations. Works with the business leaders to establish regulatory strategies to support business goals for new products and new indications for existing products along with supporting CDP and value engineering projects.Key Job Responsibilities:•Manages the direct Regulatory Affairs function for PM and all International Regulatory Affairs activities for this division.•Sets strategic direction for the regulatory affairs function and ensures alignment to division business objectives globally.  Act as Regulatory Affairs business partner to the divisions and principal spokesperson for the function within the divisions.•Has direct responsibility to manage Regulatory Affairs personnel, strategies, systems, initiatives, and financial resources for the division Regulatory Affairs organization that is responsible for product submissions, regulatory strategies, and other regulatory activities.•Actively participate in Company, FDA, and Notified Body inspections including responding to observations, securing agreement of corrective actions, and participating in the implementation of corrective actions  â€˘Provide regulatory consultation and expertise to ensure the product requirements, documentation, and regulations are strictly adhered to.•Implement, develop and maintain department procedures and systems, with a focus on continual process improvement.•Participate in the divisional strategic planning process in establishing regulatory and cross-functional goals for the divisions.•Develop annual budget including capital and operating budget proposals across all divisions.  Manage departments within approved budgets.•Maintain effective relationships and integrate activities with Medtronic Corporate, MITG, Regions, and other RGI departments.•Attract, hire, train, develop, motivate, review and manage talent to assure continuity of efficient Regulatory Affairs department operations.•Proactively investigate, identify, and implement best-in-class Regulatory Affairs practices and recommends programs or projects for the divisions.•Assist in the development of protocols related to product validations/verifications or clinical studies as necessary.  â€˘Periodically draft, review and revise Regulatory Affairs Procedures or other department operating procedures and assume accountability for all such procedures in the assigned areas•Participate in root cause analysis/failure investigations when necessary. â€˘Support Standards Updates for adherence to latest versions of Product and Quality System Standards. Examples of such Standards include IEC 606101, ISO 13485, ISO 14971 etc.•Participates in any safety issue evaluation and recall decision making per MITG/MDT procedures.Must Have: Minimum Requirements â€˘ Bachelor’s degree• Minimum of 10 years of regulatory experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of regulatory experience with 7+ years of managerial experience• In depth knowledge of healthcare industry, environment and GPOs/IDNs Nice to Have•Experience with FDA and ISO audits, practical experience with ISO 13485, QSR, ISO9001•Ability to influence others•Excellent interpersonal skills are a must to be effective in a matrix organization and with customers. â€˘Excellent organizational and managerial skills Strong team player and mature personality that works effectively on cross-functional teams, with medical and non-medical professionals at all levels and in an international environment.•Excellent communication skills.•Computer proficiency with Excel, Word, PowerPoint, Outlook•Experience with analytical tools and dashboard generation•Excellent verbal and written English skillsAbout MedtronicTogether, 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.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 Day in the Life 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.EEO 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

 

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Posted on

Type

Executive / senior industry position

Boulder%2C%20United%20States

Boulder , United States