Director, RA (R&D/NPD)

Øresund region, Nordics

BRIEF COMPANY PROFILE
Our client is a global leading provider of software embedded medical devices that help healthcare professionals set appropriate diagnosis of critically ill patients. The company is located in the Øresund region.
THE POSITION
As Director, RA the role will be heading up the RA team supporting one of the bigger business areas of our client. The team consist of 10+ FTE’s – hereunder 1-2 Managers. The role will lead a truly global team that works together across borders in RA and with their partners in the organization. The role will be responsible for supporting RA activities related to R&D/NPD projects, compliance, life cycle management and improvement projects. The team will generate documentation to support approval in EU, US & CHN of the designated products. This documentation will be handed over to the Int. Registration team that will be ensuring submissions to the rest of the world.

POSITION PROFILE
Position title:	Director, RA (R&D/NPD)

Reporting line:	Global Director, RA.

Reporting to the position:	10+ reports/1-2 Managers

Location:	Øresund region

Traveling:	Expected to be approximately 10%.

Responsibilities & Tasks:	Supporting RA activities related to R&D projects, compliance, lifecycle management, and improvement projects. Being responsible for ensuring that documentation is generated in R&D projects to support the main markets; i.e. EU, US & CHN Interpreting regulations, standards & guidance documents, and providing input to the organization of such. Ensuring that RA change assessments and impact assessments are made in support of design changes. Ensuring that RA reviews and provides feedback to marketing material. Participating in process improvements and creation of SOPs in the RA area.

Key success criteria:	Successfully building and leading a cohesive and high performing RA organization working collaboratively across all parts of the organization, making sure all projects are completed on time and with an appropriate level of documentation. Trending and learning from feedback from authorities (mainly EU, US & CHN) to make sure such learning is shared with the rest of the organization for improvement. Successfully collaborating internally in RA and with cross-functional stakeholders and teams in QA, R&D, Production, Sales & Marketing and other departments. Setting clear internal direction & strategy for the team and ensuring seamless execution.

CANDIDATE PROFILE
Educational background:	The preferred candidate holds a Masters Degree, PhD, or Doctorate in Science, Engineering, Pharmacy, Biology, Biochemistry or the like.

Language:	English – fluent (verbally and written)

Ideal experience:	5+ years of RA manager experience leading a RA team working on NPD projects. Strong RA knowledge and experience with medical device legislation (MD and/or IVD) specifically in EU, US and CHN. Extensive experience with design control and RA activities related to this. Experience with country specific labeling of MD/IVD medical devices. Prior experience in setting the direction/strategy for a department. Well-versed in daily management activities incl. delegation and prioritization of tasks. RA life cycle management experience. Successful experience taking a product from development through to global regulatory approval. Promotional item and labeling approval experience.

Personal & leadership competencies:	Leadership Leads by example; possesses demonstrable leadership skills and can move others to action, including employees, peers, and superiors. Demonstrates a positive, results-oriented style. Develops others, and manages performance of team through coaching and feedback, willing to share personal knowledge and experience with others. Initiative Is proactive and able to inspire others and is able to take own initiatives without hesitation. Actively seeks influence and starts up actions on own initiative. Team orientation Empathetic, energetic, and capable of building a strong organization based on collaboration. Interacts and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information. Visionary/strategic mind Defines a clear vision. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies. Structure Works systematically; organizes work and effort; is methodical in one's performance; holds on to commenced tasks and projects. Results and goal orientation Establishes visible and achievable goals for the department. Focus on action, activities, and results. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed. Inspiration and motivation Possesses a proactive and dedicated work-spirit; inspires others, encourages the achievement of set goals by promoting a sense of purpose, provides inspiration for a positive work attitude, prompts a strong wish to succeed in the team. Secures a feeling of mutual respect in the team through empathy and trust. Assertiveness  Makes a good first impression and displays a high degree of empathy, trustworthiness, and presence. Continuous improvement Champions the philosophy of continuous improvement challenging the status quo and raising the standards. Collaborative Excels in cross-functional teams. Possesses the ability to secure open communication based on mutual trust in team, but likewise with cross-functional, cross-organizational, and cross-geographical stakeholders. Communication Communicates the central issues in a discussion in an open, fluent, and precise manner, meanwhile being able to keep the recipients' attention and being attentive to the needs of others when he/she speaks. Possesses excellent presentation and facilitation skills. Flexibility Is able to work in an environment with changing priorities daily.

Director, RA (R&D/NPD)

BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

CANDIDATE PROFILE

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