Global Director, RA (Int. Registrations)

Greater Copenhagen, Denmark

BRIEF COMPANY PROFILE
Our client is a global leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. The company’s advanced solutions and products help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal care and wound care. The company is located in Greater Copenhagen.

THE POSITION
As Global Director, RA (Int. Registrations) you will be heading up the Global RA team which consists of 17-20 FTE’s with 3 Senior Managers/Managers and a Subject Matter Expert reporting directly to the position. It’s a truly global team that works together across borders in RA and with their partners in the organization. The role will be responsible for international registrations, country specific labeling, regulatory intelligence, a China specific team and work closely together with stakeholders worldwide. The global RA team is tasked to ensure market approvals for our clients different product areas. Successful execution of this task depends on cross-functional cooperation with QA, R&D, Production, Sales and Marketing and other departments.

POSITION PROFILE
Position title:	Global Director, RA (International Registrations).

Reporting line:	Global Senior Director, RA.

Reporting to the position:	4 Direct Reports/17-20 FTE’s.

Location:	Greater Copenhagen.

Traveling:	Expected to be approximately 10%.

Responsibilities & Tasks:	Overlooking international registration by ensuring approvals worldwide. Developing a strategy for the global RA function and participating in cross working groups. Monitoring the legislation and being able to translate and implement it at our client. Maintaining market approvals and current documents within responsibility area. Supporting the RA labeling team with country-specific labeling. Participating in process improvements and creation of SOPs in the RA area.

Key success criteria:	Successfully building and leading a cohesive and high-performing Int. registration organization working collaboratively across all parts of the organization, making sure all approvals are on time. Delivering on RA KPI’s – e.g. related to submissions subsidiary response time a.o. Successfully collaborating with subsidiaries and distributors as well as cross-functional teams in QA, R&D, Production, Sales and Marketing and other departments. Setting clear internal direction & strategy for the Int. registrations area and ensuring seamless execution. Developing and managing a continuous improvement culture.

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 manager experience leading in a Global environment. Strong RA knowledge and experience with medical device legislation (MD and/or IVD) on different markets worldwide e.g., EU, MDSAP countries, Korea and LATAM. Experience with international registrations and work relations with different cultures. 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.

Global Director, RA (Int. Registrations)

BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

CANDIDATE PROFILE

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