Regulatory Affairs & Compliance Specialist
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Middelfart
Do you have experience with medical devices, and do you want to influence regulatory compliance and future medical product development in a global company?
Ensure documentation of medical device products
We are on an exciting path of growth and are currently seeking a talented and motivated specialist to join our team. The ideal candidate will play a crucial role in ensuring that our operations adhere to relevant regulations and industry standards. If you have a strong background in compliance and a passion for maintaining ethical business practices, we invite you to apply.
Through your position you will immediately impact regulatory compliance and future product development and launch, just as you will also ensure compliance on our existing product portfolio, delivering valuable information to the regulatory department ensuring the right external product registration.
Ensuring new standards and recertification
As a team member in the regulatory and compliance team, you will be involved in regulatory surveillance and safety related risk analysis ensuring new standards and recertification are handled and new standards implemented in our knowledge base.
A significant part of your role will be to take part in planning and implementing the required documentation, including usability engineering and risk management, in compliance with current regulatory standards for medical device development. Working side-by-side with our developers and regulatory compliance team members, you will be responsible for and delivering:
• Conduct regular internal audits to assess compliance with applicable laws and regulations.
• Develop and implement policies and procedures to ensure compliance with industry standards.
• Collaborate with cross-functional teams to integrate compliance requirements into business processes.
• Stay informed about changes in relevant laws and regulations and communicate updates to the team.
• Respond to compliance inquiries and provide guidance to internal stakeholders.
• Assist in the development of training programs to educate employees on compliance-related matters.
What you need to succeed and create results
• Relevant engineering degree or similar technical background from the medical device industry
• Proven knowledge and experience in MDR 2017/745.
• Proven knowledge and experience in Risk Management (ISO 14971).
• Advantage with knowledge of FDA 21CFR.
• Advantage with knowledge of software development standard, IEC 62304.
• Advantage with knowledge of material compliance, and biological evaluation, ISO 10993-1.
• Advantage with knowledge of Cybersecurity Risk Management.
Your contribution
Using your solid knowledge about product documentation, and requirements in the different markets you cooperate with project teams ensuring a smooth compliance process in line with the overall project plans.
We are looking for a candidate with a proven track record of regulatory compliance from a similar position. As a person you have a positive mindset and enjoy working with others as you will be collaborating with many different colleagues across the organization. It is crucial that you are diplomatic and able to coordinate the activities of the people around you. Ensuring structure and being systematic of course comes natural to you. Finally, you care about the details, and you have a "can-do" attitude.
How to Apply:
If you are looking for an exciting opportunity to contribute to an innovative company, we encourage you to apply. Please send your resume and a cover letter detailing your qualifications and relevant experience. Applications are evaluated on a continuous basis. For questions regarding the position, please contact Flemming Vinding, Vice President, Global Quality, Diagnostics, at [email protected]
Interacoustics is an equal opportunity employer. We welcome and encourage diversity in the workplace. Join us in our mission to improve the lives of those with hearing and balance challenges. Apply today and become a part of the Interacoustics team! #LI-TP1 #LI-ON
Ensure documentation of medical device products
We are on an exciting path of growth and are currently seeking a talented and motivated specialist to join our team. The ideal candidate will play a crucial role in ensuring that our operations adhere to relevant regulations and industry standards. If you have a strong background in compliance and a passion for maintaining ethical business practices, we invite you to apply.
Through your position you will immediately impact regulatory compliance and future product development and launch, just as you will also ensure compliance on our existing product portfolio, delivering valuable information to the regulatory department ensuring the right external product registration.
Ensuring new standards and recertification
As a team member in the regulatory and compliance team, you will be involved in regulatory surveillance and safety related risk analysis ensuring new standards and recertification are handled and new standards implemented in our knowledge base.
A significant part of your role will be to take part in planning and implementing the required documentation, including usability engineering and risk management, in compliance with current regulatory standards for medical device development. Working side-by-side with our developers and regulatory compliance team members, you will be responsible for and delivering:
• Conduct regular internal audits to assess compliance with applicable laws and regulations.
• Develop and implement policies and procedures to ensure compliance with industry standards.
• Collaborate with cross-functional teams to integrate compliance requirements into business processes.
• Stay informed about changes in relevant laws and regulations and communicate updates to the team.
• Respond to compliance inquiries and provide guidance to internal stakeholders.
• Assist in the development of training programs to educate employees on compliance-related matters.
What you need to succeed and create results
• Relevant engineering degree or similar technical background from the medical device industry
• Proven knowledge and experience in MDR 2017/745.
• Proven knowledge and experience in Risk Management (ISO 14971).
• Advantage with knowledge of FDA 21CFR.
• Advantage with knowledge of software development standard, IEC 62304.
• Advantage with knowledge of material compliance, and biological evaluation, ISO 10993-1.
• Advantage with knowledge of Cybersecurity Risk Management.
Your contribution
Using your solid knowledge about product documentation, and requirements in the different markets you cooperate with project teams ensuring a smooth compliance process in line with the overall project plans.
We are looking for a candidate with a proven track record of regulatory compliance from a similar position. As a person you have a positive mindset and enjoy working with others as you will be collaborating with many different colleagues across the organization. It is crucial that you are diplomatic and able to coordinate the activities of the people around you. Ensuring structure and being systematic of course comes natural to you. Finally, you care about the details, and you have a "can-do" attitude.
How to Apply:
If you are looking for an exciting opportunity to contribute to an innovative company, we encourage you to apply. Please send your resume and a cover letter detailing your qualifications and relevant experience. Applications are evaluated on a continuous basis. For questions regarding the position, please contact Flemming Vinding, Vice President, Global Quality, Diagnostics, at [email protected]
Interacoustics is an equal opportunity employer. We welcome and encourage diversity in the workplace. Join us in our mission to improve the lives of those with hearing and balance challenges. Apply today and become a part of the Interacoustics team! #LI-TP1 #LI-ON
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Middelfart.
Jobbet er oprettet på vores service den 5.12.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Middelfart
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