Senior Regulatory Affairs Specialist

At Medtronic we value what makes you unique. Be part of a company that thinks differently to solve problems make progress and deliver meaningful innovations.

This role entails implementing regulatory strategies managing regulatory submissions assessing the regulatory impact of product changes and ensuring your team delivers high-quality results through providing guidance and mentorship to team members supporting theirdevelopmentand helping them navigate complex regulatory requirements.

Collaborate closely with cross-functional partners such as R&D clinical operations and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups supporting regulatory compliance and businessobjectivessupporting Acute Care & Monitoring achieve regulatory success andmaintaina competitive edge.

The Senior Regulatory Affairs Specialist (Sr. RAS)is responsible forcollaboratingplanningand executing regulatory activities related to theAirwaysproduct portfoliowithin the Acute Care and Monitoringoperation unit. Activities include participation in change development projects review and approve design control documentation regulatory change assessments author regulatory documents (MDR Technical Documents STEDs or 510ks) and supporting EU MDR implementation.

The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally while ensuringtimelyand high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.

• Directs or performs coordination and preparation of document packages for regulatory submissions.

• Supports change control activities to support global approval andimplementation of product and process changes.

• Leads or compiles all materialsinCE-Mark and FDAsubmissions licenserenewaland annual registrations.

• Teams with business unit Regulatory Affair Specialists and internationalregulatory staff to provide regulatory support for new products/therapiesand changes to existing products. Work with engineers and technicalexperts to develop robust regulatory strategies and resolve questions fromregulatory agencies.

• Recommends changes forlabelling manufacturing marketing and clinicalprotocol/evaluation reports for regulatory compliance.

• Keeps abreast of regulatory procedures and changes. Develop internalprocedures to ensure continuous compliance with all regulatoryrequirements.

• May have direct interaction with regulatory agencies on defined matters.

• Support regulatory compliance activities including manufacturing site registration & GMP audits as needed.

• Identifiesand develops best practices within the Regulatory Affairs Department including continuous development initiatives.

• Level 8 Honors Degree Science or Engineering bachelors degree/masters with a minimum of 5 years of relevant experience preferably withClass I & Class II Medical Devices. A Regulatory Affairs qualification is desirable but not mandatory.

• Regulatory experience in Medical Devices Pharmaceuticals or similar regulated industry is.

• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.

• You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability tocomprehendprinciples of engineering physiology and medical device use.

• You collaborate with global cross functional teams and create alignment with team members.

• Experience with FDA regulatory requirements European Medical Devices Regulation (EU MDR) Regulation (EU) 2017/745 and international regulatory agency requirements.

• Experience with software and hardware medical devices.

• May provide guidance coaching and training to other employees within job area.

• You sethigh standardsand drive accountability in the execution of your responsibilities and you model ethicalbehavior.

• Ability to effectively manage multiple projects and priorities.

• Has an excellent attention to detail and are results oriented.

• Proven problem-solving skills with the ability toidentifyrisks and escalate issues asappropriate.

• Good initiative and team player.
  

Medtronic offer a competitive salary and flexible Benefits Package

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