Sr Regulatory Affairs Specialist

At 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 This position has a focus on the regulatory process accountable for providing high quality technical/administrative support as required in assessing product changes (RACs), managing and clearing GTS Blocks, supporting RFPs and Tenders, responding to regulatory queries, and promotional material reviews. Responsibilities Prepare, submit and manage applications for regulated medical products (i.e. Drugs, Devices, CTO, Others) to meet the regulated agency requirements and ensure follow up until approval.• Strategic Regulatory Lead for a local Business Group to ensure timely market access and maintenance through products registration, well aligned with the market strategies.• Drive/Lead meetings and interface with the Medical Devices Bureau and other pertinent regulatory bodies (for drug, natural health products and biologic products, telecommunication products etc.).• Represent Medtronic of Canada objectives/requirements with Global Partners• Ensure regulatory compliance.• Ensure compliance with Medtronic and Medtronic of Canada Quality Management System, policies, procedures and work processes.• Ensure regulatory activities are performed to established schedules and budgets.• Liaise with Operating Units to respond to RACs in a timely manner• Review and assess RACs to ensure compliance with Canadian Regulations• Respond to Health Canada, Physician, and Field Personnel request for additional information• Manage and resolve GTS blocks and regulatory queries • Assist in managing annual license renewals (MDEL/DEL/CTO)• Manage and actively participate in Enterprise and local initiatives for all products licensed for sale in Canada to ensure accuracy of information• Ensure all regulatory activities involving the importation and distribution of medical devices, natural health products and drugs are in compliance with their respective regulations• Participate in Quality and Regulatory compliance initiatives including writing and/or revising Standard Operating Procedures for Work Instructions.• Provide support for Tenders, RFPs and customer requests• Ensure all regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes. MAIN JOB DUTIES/RESPONSIBILITIES Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of 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.• Keeps abreast of regulatory procedures and changes.• May direct interaction with regulatory agencies on defined matters.• Recommends strategies for earliest possible approvals of clinical trials applications.• Responsible for reporting complaints and Adverse Drug Reactions (ADR)• Maintain up-to-date knowledge of Canadian Medical Devices Regulations and Guidelines for licensing of Medical Device/Drug products, Food and Drug Act and Regulations, and Natural Health products Regulations.• Familiarity with ISO13485:2003 “Medical Devices – Quality Management Systems” and Medtronic of Canada.• Regulatory responsible contact and member of Business Unit Leadership team/meetings, to address business challenges, development of long range planning within the regulatory context. Responsible for defined portfolio, gap analysis, development of strategic plans to grow the business, mitigate risk, resolve deficiencies and technical issues.• Develops the Canadian regulatory licensing strategy. Identifies required elements foreach submission and/or long range plans in collaboration with Medtronic of Canada Marketing Manager(s) or Divisional Director(s), with the objective to accelerate market access and negotiate with regulator when required.• Negotiate prioritization/plan with BU for submissions according to BU and Medtronic of Canada Divisional product strategies.• Ensure proper elements of product submissions are collected from BU’s, prepared, and submitted in a timely manner.• Leadership with Agencies in area of expertise and portfolio responsibility.• Organizes agency meetings in support of Medtronic product development, goals and objectives.• Advocate/influence with global partners as required to support local strategies.• Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.• Collaborate with the Regulatory Team, Regulatory Officers as well as Operations Management to innovatively address regulatory issues and support achievement of Regulatory Compliance.• Implement new and proposed regulations and guidelines published by governmental regulatory authorities as they apply to Medtronic products.• Participate in Quality and Regulatory compliance initiatives including writing and/or revising Standard Operating Procedures.• Ensure all regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes. KNOWLEDGE/EDUCATION Bachelor’s degree in Life Sciences Knowledge of products and therapies. Knowledge of TPD Ottawa Bureau. Professional Relationships (Health Canada, Associations). Knowledge of Canadian Medical Device Regulations, ISO Medical Device Standards(13485:2003). Food and Drug Act and Regulations, Safety of Human Cells, Tissues and Organs for Transplantation Regulations JOB EXPERIENCE Minimum of 4 years of relevant experience in Regulatory Affairs. Proven experience with drug and device regulatory/submission process. Regulatory Agency experience. Business Development. Direct experience negotiating/working with Health Canada representatives to meet business objectives while ensuring safety/efficacy. SKILLS/COMPETENCIES Demonstrated leadership competencies. Effective at influencing and building strong working relationships across all levels. Negotiation Skills. Technology Expertise. Business Acumen. Demonstrated organizational abilities. Good Communication skills. Excellent Computer Skills. Medtronic Competencies. Strong interpersonal and communication skills at all levels of the organization. Proven track record of good judgment. Demonstrated integrity and respect for all. Attention to detail. Strong problem solving and results driver. Ability to manage multiple priorities in a fast‑paced environment. DESIRED/PREFERRED QUALIFICATIONS KNOWLEDGE/EDUCATION Advanced degree (M.Sc. or Ph.D.). JOB EXPERIENCE Minimum of 2 years relevant experience in R&D experience. SKILLS/COMPETENCIES International experience. French communication skills. SPECIALIST CAREER STREAM Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in‑depth in nature and often provides recommendations on process improvements. Communication and Influence Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision‑making. Leadership and Talent Management May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. 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. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A 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. 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 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here #J-18808-Ljbffr