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 LifeReporting to the Manager Regulatory affairs, the Specialist, Regulatory Affairs will evaluate, develop and recommend strategic submission pathways, options and strategies for departmental assignments. He/She will prepare the various medical devices applications and combined product submissions to meet with regulatory agency requirements and ensure follow-up until approval. Furthermore, he/she will support quality related tasksResponsibilities 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 clinical trials applications.
- Responsible for reporting complaints and Adverse Drug Reactions (ADR)
- Maintain ongoing dialogue with business partner(s) to develop strategies aligned with the business plan.
- Liaise with Business Unit to obtain the proper product and technical documents for the purpose of preparing license applications for filing in Canada.
- Responsible for the timely completion of regulatory submissions and applications and related amendments.
- Maintain professional relationship with Health Canada.
- Ensure all regulatory records/documents are properly and adequately maintained in accordance with regulatory requirements and internal processes.
- Support or lead special Regulatory business projects and assignments as required.
- Collaborate with Marketing and Global Regulatory Teams on a regular basis to assess and prioritize submissions to Health Canada.
- Participate in product launch activities as required.
- Ensure compliance with government regulations by providing Health Canada with all necessary technical information relating to changes or modifications to regulated medical products (i.e. Drugs, Devices, CTO etc.).
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.
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 2 years of relevant experience, or advanced degree with 0 years of experience.
REQUIRED QUALIFICATIONS
KNOWLEDGE/EDUCATION
• Bachelor’s degree, or;
• Advanced degree in Life Sciences
JOB EXPERIENCE
• Minimum of 2 years of relevant experience, with a bachelor’s degree, or;
• No minimum years relevant experience, with an advanced degree.
• Experience in the preparation and filing of regulated medical product applications.
• Strong problem solving and organizational skills and able to work with minimum supervision.
• Detail oriented, accurate and results driver.
• Ability to think strategically and work in cross-functional teams.
• Ability to manage multiple priorities in a fast-paced environment.
• Team player with very strong interpersonal skills.
• Excellent verbal and written communication skills.
SKILLS/COMPETENCIES
• Working knowledge of the Food and Drugs Act and associated Regulations.
• Knowledge of Quality System Requirements.
• Must be computer literate using Microsoft software (i.e. Word, Excel, PDF, etc.).
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DESIRED/PREFERRED QUALIFICATIONS
KNOWLEDGE/EDUCATION
• Postgraduate certificate in Regulatory Affairs.
• Knowledge of Cybersecurity and/or Artificial Intelligence as an asset
• Knowledge of CTO Regulations
JOB EXPERIENCE
• 3 - 5 years of relevant experience
SKILLS/COMPETENCIES
• Bilingual French/English
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.
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.
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
