Principal Regulatory Affairs Specialist – Renal Care Solutions (RCS) (within Minimally Invasive Therapies Group (MITG))
The Principal Regulatory Affairs Specialist (Prin RAS) is responsible for worldwide product approval submission activities and regulatory compliance for acute and chronic renal replacement products. Develops strategies for worldwide governmental approval to introduce new products (Class II & III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. Collaborate with R&D, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle.
MAIN JOB DUTIES/RESPONSIBILITIES
• Develop global regulatory strategies for medical device and combination product to meet business objectives.
• Participate on Product Development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
• Organize, prepare, and author complex high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Support regulatory compliance activities, including manufacturing site registration, GMP audits, post-market vigilance reporting, product recalls, assessing impact of new and changing regulatory requirements, etc., as needed.
• Drive product change assessments and define regulatory impact of product changes in global markets.
• Review and approve labeling, training, promotional, and advertising material.
• Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Medtronic, U.S. FDA, and international requirements.
• Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.
• Interpret and execute policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures. Create departmental procedures.
• Participate on audit and field action teams
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide business and product information to international regulatory staff to enable development of strategies and requirements and communicate that information to business teams.
• Provide feedback and on-going support to product development teams for regulatory issues and questions.
• Travel internationally up to 10%.
MITG/RENAL CARE SOLUTIONS (RCS)
The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
The Renal Care Solutions Group(RCS), within 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 $29.7b company with 90,000+ employees in more than 160 countries.
Come for a job. Stay for a career.
Minimum Required Qualifications (Must be evident on your resume): EDUCATION REQUIRED
• Bachelor's Degree in science, math, or engineering discipline. Advanced degree desired
YEARS OF EXPERIENCE
• 8+ years in the medical device industry with Regulatory Affairs experience with Bachelor’s Degree.
• 5+ years in the medical device industry with Regulatory Affairs experience and Master’s Degree.
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
• Experience with PMA, IDE, De Novo, and/or 510(k) product and submissions. 510(k) experience desired.
• Experience in supporting Class III device or IIb active medical device European Technical documentation and Submissions.
• Experience with Pharmaceutical or Combination product
• Highly proficient in spoken and written English.
• Experience with negotiations/interactions with regulatory agencies/health authorities is preferred.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• 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
• Presentation skills for small to mid-sized groups
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Knowledge of Quality System requirements and FDA and/or International product approval process. Physical Requirements: 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. 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.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car(10 - 20%), including International travel. MITG/ Renal Care Solutions (RCS) Overview The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. The Renal Care Support (RCS) Group, within the Minimally Invasive Therapies Group, brings together Medtronic and Covidien’s experience advancing renal care through innovative design. Dialysis presents a unique set of challenges. Vascular access is critical to treatment and vulnerable to clotting and infection, some of the leading causes of catheter failure. We are leading the way by providing clinical solutions. Our acute, chronic and peritoneal dialysis catheters are designed to improve flow rates, reduce the risk of clotting, increase patient comfort and provide ease of use for clinicians. Our catheters help you meet the clinical demands of treating patients who need hemodialysis, apheresis, infusion, central venous pressure monitoring and high-pressure contrast injection.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 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 $29.7b company with 90,000+ employees in more than 160 countries.
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.
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.