Regulatory Affairs Specialist - 18 months Contract

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeResponsibilities may include the following and other duties may be assigned. 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 Health Canada applications. Additional Responsibilities: Define the regulatory strategy and manage regulatory submission activities for product maintenance for existing approved products. Team with other Regulatory Affairs Specialists (RAS) and international regulatory team to provide regulatory support changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare regulatory submissions for product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Interact directly with regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide local regulatory assessments to international regulatory team to enable development of strategies and requirements and communicate that information to business teams. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. 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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. • Bachelor’s degree required • Minimum of 2 years experience in regulatory affairs, preferably in the medical device industry. • OR advanced degree with 0 years of experience in the medical device industry. Nice to Have: • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). • Proficiency in assessing changes to labeling, design, materials and manufacturing for impact to Canada, US and EU requirements. • Experience with Health Canada and international regulatory agency requirements. • Effective interpersonal skills and team member. • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills. • Ability to effectively manage multiple projects and priorities. • Proficient computer skills and experience with REP / IMDRF. • Project management skills. • Excellent oral and written skills. • Excellent analytical thinking skills. Salary Range: $73,520 - $91,900 PLEASE NOTE: We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting. We do not use AI to make any final hiring or interview decisions. This posting reflects a current, genuine vacancy that we are actively recruiting to fill. PHYSICAL JOB REQUIREMENTSThe 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: 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. Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community. Upon request, candidates with disabilities will be accommodated during the recruitment process. 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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. ‌ Benefit