SENIOR REGULATORY AFFAIRS SPECIALIST
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Senior Regulatory Affairs Specialist
is responsible for developing regulatory strategy, preparing U.S. and EU submissions and obtaining approval to introduce new Medtronic products and therapies to markets worldwide.
A Day In The Life
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products/therapies; and develops strategies that leverage opportunities and experiences across functions. Influences and inspires alignment with business goals, internally and externally.
Leads preparation of FDA submissions (including IDE and PMA submissions, amendments, and supplements, de novo, 510(k)s) for new products and product changes as required to ensure timely approvals and market release. Review submission decisions/content issues with manager. Negotiate submission issues with agency personnel; lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies; establish and maintain good relationships with agency personnel.
Lead preparation of EU technical files and design dossiers for new products and product changes to ensure timely approvals and market release. Review submission decisions/content issues with EU international regulatory staff; work through any submission issues from agency; lead cross-functional team efforts to resolve potential regulatory issues and questions from regulatory agencies.
Participates as a core member on development teams to provide regulatory guidance, and develop regulatory strategies, and identify deliverables needed; effectively communicates project plans, status and resource requirements to both core teams and senior management; plays leadership role in effectively planning and driving successful completion of complex cross-functional projects.
Maintain proficiency in worldwide regulatory requirements; monitor changes to regulatory requirements and communicating this information to departments within the business unit that may be affected by these changes; establish and maintain good relationships with agency personnel.
Monitor and interpret latest FDA regulatory environment and assess impact to new product development projects and existing business procedures and practice.
Review and Revise SOPs, and other company and departmental procedures to ensure quality system compliance.
Performs other duties as assigned.
Ability to travel up to 10%
Must Have; Minimum Requirements
Minimum 4 years of regulatory experience or Master’s degree with 2+ years of regulatory experience
Experience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)
Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, drug or biologics submissions)
Nice To Have
Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field
Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews
Experience with regulatory support of clinical trials
Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
Regulatory Affairs Certification (RAC)
Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results
Organized, efficient, process-oriented; high attention to detail
Effective interpersonal/communication skills
Works well under pressure in a dynamic timeline-driven environment
Ability to effectively manage multiple projects and priorities
Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
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.
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.
Website : http://www.medtronic.com/
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Groups products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.