Medtronic Associate Regulatory Affairs, Nordics in Norway
Associate Regulatory Affairs, Nordics
Jan 13, 2021
A Day in the Life
To support our Regulatory Compliance activities in the Nordic countries we are currently looking for a fulltime Associate Regulatory Affairs Specialist. You are an excellent communicator and enjoy supporting the commercial business units with your advisory and instructions.
This is a great challenge to get onboard in an experienced Regulatory Affairs (RA) Nordic team. Your dedicated task is to support and advice the sales team to assure compliance with all local Nordic legislation applicable to Post Market Surveillance as well as competent authority, hospital customer engagement and tenders.
Come and join our Medtronic promotion on environmental stewardship!
The health of the planet is vital to the health of society. Therefor were reducing our use of the natural resources we all rely on and invest in renewables to sustainably power our global operations and set the goal to be carbon neutral in our operations in 2030.
Further details you can find on https://www.medtronic.com/us-en/about/citizenship/promoting-environmental-stewardship.html
Field Actions and Product Hold
Act as the responsible person within Regulatory Nordic in the preparation, execution and follow up of field safety corrective actions and product holds. (this includes the correct update of the Medtronic reporting systems and record keeping in an electronic database).
Attending Field Safety Corrective Action (FSCA) meetings with the European regulatory affairs core team and colleagues from other European countries.
Organize weekly follow-up meetings with sales managers and sales representatives of Medtronic sales force at the hospitals within the Nordic countries.
Ensure a close collaboration with sales representatives to collect records/evidence allowing the closure of the field action.
Competent authorities Inquiries
Follow up on Inquiries from the competent authority Lgemiddelstyrelsen, DKMA in Denmark; Lkealan turvallisuus- ja kehittmiskeskus Fimea, FiMEA in Finland; Lyfjastofnun, IMA in Iceland; Statens Legemiddelverket, NoMA in Norway and Lkemedelsverket, MPA in Sweden related to vigilance activities (this includes updating of the Medtronic reporting systems and record keeping).
Complaint Handling Support
Provide advisory to the sales team members on the product complaint handling process and returns to assure compliance to Nordic legislation, regulations, and Medtronic procedures.
Quality Regulatory Support
To support the Medtronic matrix organization, you have to support multiple Regulatory Quality activities within the Nordic countries, related to the certified Quality Management System (according to EN ISO 13485:2016) of the Nordic Region, i.e. Supplier Management, Distributor Management, Document Control, Key Performance Indicators (KPI) monitoring, approve local marketing projects and follow up on new regulations.
Support Tender Customer Requests handling
Liaise with Operating Units and EMEA plant regulatory colleagues to obtain product technical information (declarations of conformity, CE certificates, artwork etc.)
Check different databases to obtain the necessary data/information and provide feedback to tender team, sales teams and customers.
Bachelors degree in engineering, life-science, biology or relevant
Fluent in one Nordic language and English
Ability using Microsoft Office Suite and handling knowledge databases on a super user level
You have an eye for detail and enjoys delivering quality in your work and proceed with integrity
you are an outstanding communicator and thrive to be effective and balancing time vs. deadlines
You enjoy continuous Learning and are being proud to deliver quality and confident to share smarter ways of working into your team and present innovative ideas on RA professional area.
Is this the position you were waiting for? Then please apply directly via the apply button!
At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe its the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veterans, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer your unique perspectives, talents and contributions we can live up to the promise of our Mission.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.