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Regulatory Affairs Professional – Medical Devices

Elos Medtech Pinol A/S
Gørløse

At Elos Medtech we give you the chance to grow. To shape your own career. To work in an international environment. To be part of a company that supports the global implant market. We offer you a world of opportunities – if you have the ability and the drive to take them.

Exciting new opportunity for a Regulatory Affairs Professional to join our dedicated Regulatory Affairs team based at our site in Gørløse (Hillerød), Denmark.

We are looking for a Regulatory Affairs professional with the competence and ambition to take on the role as manager for the Regulatory Affairs team—either immediately or by growing into the role over time.

As a Regulatory Affairs Professional, you will ensure regulatory compliance with Elos Medtech medical devices and maintain our licenses to sell to different markets.

Your new team:

The position is in Elos Medtech in Gørløse. Joining us, you will be part of a team of 3 experienced Regulatory Affairs Professionals. The team is a part of the R&D dental group supporting different aspects of quality and regulatory affairs (post market surveillance, vigilance, regulatory compliance).

Empowerment, trust, and high level of personal commitment characterize our work environment.

Main responsibilities:

  • Ensure regulatory compliance to maintain and obtain market approvals
  • Regulatory support to enquiries from customers and authorities
  • Review, interpret and communicate FDA/EU/MDSAP/international regulations and guidance documents to ensure complete regulatory submissions
  • Write and submit 510(k)s and EU MDR technical documentation and interface with authorities during the review process
  • Regulatory review of promotional material
  • Participation in cross-functional projects delivering regulatory advice / strategy
  • Overview of PSUR/PMSR, PMCF plan/report, SSCP and ensure timely compliance
  • Support internal and external audits and inspections with documentation and regulatory expertise
  • Act as liaison for regulatory matters, ensuring timely communication with Notified Body for compliance

We work in cross-functional teams, and you will work in collaboration with, Product Development team and our Global Dental Product Sales & Dental Marketing team. As the position is highly characterized by delegation, you must be ready to take responsibility. In your daily work, you will report to Henrik Andersen, VP R&D Dental.

Education:

  • Bachelor’s or master’s degree in life sciences, engineering, law or similar

Experience:

  • RA experience from Medical Device with working knowledge of European and International regulatory requirements i.e., US, Canada, Australia, China, Japan will be preferred.
  • Experience with Class I and IIb implantable medical devices.

Knowledge, Skills, Abilities:

  • Critical thinking skills with attention to detail as well as ability to maintain visibility of the greater picture.
  • Organized, structured and decisive with the ability and willingness to work in challenging situations.
  • Good communication skills in Danish and English adept with communication at all levels as well as with customers/stakeholders in a professional and effective manner.
  • Committed, proactive and self-driven with a positive mindset, flexibility, and persistence.
  • Working knowledge of ISO 13485 and regulatory requirements for medical devices (including MDR, FDA CFR 21 part 820).
  • Working knowledge of EN ISO 14971 and experience in utilizing Risk Management techniques for medical devices is a plus.
  • Demonstrated leadership potential, with the ability to coordinate work, set direction and priorities, and drive progress across the Regulatory Affairs area.
  • Ability to coach and support colleagues, give constructive feedback, and contribute to a strong team culture and ways of working.
  • Strong stakeholder management skills, including the ability to influence without formal authority and communicate clear expectations and decisions.

Working conditions mean something for us:

In addition to an exciting position as well as a salary that reflects your qualifications, you will be part of a company that prioritizes good working conditions for its employees. We offer, among other things, continuing education, leadership program, pension schemes, canteen and fruit, health insurance, massage and a well-equipped gym.

Short periods of travel activities in relation to customer projects may occur.

Contact:

Please apply as soon as possible. Applications are accepted in English and Danish. We will review applications and hold interviews on an ongoing basis until the position is filled.

For further information about the position, feel free to contact Henrik Andersen, VP R&D Dental: henrik.andersen@elosmedtech.com / +45 21 45 42 84.

We look forward to receiving your application!

Elos Medtech is one of Europe's largest development and production companies within dental technology. We provide turnkey solutions for dental professionals all over the world. We offer dental implant components and instruments for a digital workflow as well as a well-proven standard prosthetic solution for a traditional workflow to serve the different needs of dental professionals including dentists and dental technicians. We work in a friendly and easy-going atmosphere where good collaboration based on mutual respect is a key virtue.

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