Lukket rekruttering

Head of Regulatory Affairs

Oticon / Fuldtid

Do you have extensive experience with Management of Regulatory Affairs Portfolio? Would you like to oversee regulatory affairs activities in an international set­up? Are you attracted by the possibility of leading a highly qualified Regulatory Affairs team in one of the World’s leading companies within hearing solutions?

Then we might have an exciting opportunity for you in our company.

Supporting the organization

In your new position, you will become Head of the Regulatory Affairs department, which is responsible for the regulatory strategy for each project and for project support throughout the product development process. We are a small and dedicated team of 9 people situated in Denmark and Poland. At the end of 2017 additional 3 positions will be transferred from
Bern to Denmark.
Among other tasks, the team is managing classification activities, risk management file processes, device registrations, radio and electrical safety test and approvals plus standard and regulation requirements. Furthermore, the team is involved in internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820 and we are continuously involved in improvement projects.
The job
You can look forward to a wide range of challenging tasks, but your main responsibility will be management of the Regulatory group and resources, which includes:

• Daily people management of the RA­teams in Denmark and Poland
• Overall planning and follow­up on regulatory support to R&D projects
• Reporting on Regulatory project activities
• Managing the regulatory portfolio for R&D projects.
• Managing the departments participation in R&D projects
• Creating overview of relevant compliance requirements and aligning relevant documentation.
• Supporting the export department in homologation in local countries.
• Handling communication with Notified Bodies conc. CE­marking
• Handling audits and inspections with respect to own department and responsibility area.
• Developing the RA strategy making long term plans on new initiatives and KPI’s.
• Concluding on the regulatory activities in R&D projects.
• Reviewing of regulatory documentation.
• Approval the regulatory documentation

Your qualifications and experience

In order for you to be a success in this job, it is vital that you have experience from similar jobs, preferably from a medical device or pharmaceutical industry.

We expect you to hold a B.Sc. or M.Sc. in engineering (Medico, Electrical, Mechanical or similar) in combination with more than 5 years of Management experience, and also with RA disciplines in relation to Medical devices, preferably in a large international organization.

As a person, you have great leadership skills, you communicate in an open, direct and convincing way. You are a good supervisor who can maintain overview, and are able to multitask and stay calm in stressed situations.

Furthermore, you are a self­motivated, outgoing, curious and analytically strong team player who is able to create and maintain good relations with stakeholders. You are adaptable and characterized by your drive and willingness to get things done. You have a good business understanding and know how the regulatory affairs area influence the business. Also, you have a systematic approach to your work, and you have better than average ability to understand complex ideas, concepts and connections.

You are fluent in English and Danish, both written and spoken, and very experienced MS Office, Database Systems and documentation systems user.

You are able to travel up to 20 days per year.

Oticon dare to make a difference

Together with ambitious and talented colleagues, you will be part of a dynamic environment based on trust and openness, and where you will experience a strong will to win. We are a growing international company where everyone supports the business in order to ensure that customers find that our products are the most attractive to work with. We are located in a light and open building, where flexible work environments, knowledge­sharing and mutual
professional respect make it fun and meaningful to be here.

Capax assist the Recruitment. For further information please contact Christina Just on cj@capax.dk