GLOBAL DIRECTOR, RA
BRIEF COMPANY PROFILE
Our client is a global market leading MedTech company headquartered in the Öresund region with several years of history developing, manufacturing and selling innovative products globally to health care professionals.
The Global Director, Regulatory Affairs will assume full responsibility and leadership of the global RA function and team of dedicated RA professionals at our client and contribute significantly to defining and sharpening the future RA organization, navigating people, business and customer needs. The position will be responsible for all aspects of Regulatory Affairs, while also undertaking responsibility of the RA team, which currently consists of 10 direct reports.
Consequently, the position calls for a senior and highly experience international RA executive with a proven track record of strong organizational leadership, building effective teams in the medical device industry and potential to lead multiple layers. Moreover, the ideal candidate has demonstrable successor capabilities.
The ideal candidate display strong strategic and tactical leadership capabilities, is visionary and communicative, while being well-versed in bridging Regulatory Affairs to the business.
Global Director, RA
Greater Copenhagen, Denmark
15-20 days per year
Responsibilities & Tasks:
Developing and implementing regulatory strategies and plans to support the company product roadmap.
Motivating, developing and coaching the RA team to deliver on department goals and ambitions.
Acting as PRRC (Person responsible for regulatory compliance) for all products globally, hereunder ensuring:
The conformity of all devices is appropriately checked, and in accordance with the QMS.
Technical documentation and the EU declaration of conformity are drawn up and kept up to date.
Post-market surveillance obligations are compiled in accordance with EU regulations.
Reporting obligations referred to in EU regulations are fulfilled
Obtaining and maintaining global registrations of medical devices in compliance with current local requirements.
Staying informed on regulatory changes and evaluating them in a timely manner to secure readiness for regulatory impact – hereunder communicating changes and their impact to the organization.
Ensuring the management of timely updates of post market reports and regulatory intelligence processes.
Ensuring the development of clinical evaluations and collection of clinical evidence to support product claims.
Ensuring an effective working relationship with FDA, NMPA, Notified Body and other regulatory authorities on submissions and vigilance.
Key success criteria:
Ensuring sound compliance in accordance with regulations.
Ensuring strong performance of the global RA team and processes.
Successfully creating and executing regulatory strategies.
Successfully driving cross-functional stakeholder collaborations, alignment and communication.
Ensuring seamless cooperation with key stakeholders.
Securing timely delivery on registrations and projects, while managing resource allocation and task delegation successfully.
University level degree, preferably M.Sc., within Science, Engineering, Medical or Technical field.
Fluently oral and written English.
Ideal experience and competencies:
+5 years’ experience as a manager within quality or regulatory.
+4 years' professional experience with increasing responsibility in Medical Device RA, including demonstrated success as leader of an RA or QA/RA complex business unit.
+3 years’ people leadership experience preferably within a global setting.
Profound experience with regulatory strategies and regulatory approvals, alongside international audits and regulatory authority negotiation experience.
Technically adept understanding of the Medical Device market and associated technologies.
Preferably proven track record with problem solving and continuous improvements.
Preferably extensive experience in a similar position in an international medical device setting.
Experienced in cooperation with relevant authorities.
Experienced in adapting to changes in applicable regulatory requirements.
Defines a clear vision and looks beyond and immediate difficulties to focuses on long-term objectives and consequences. View things in a broad perspective and takes environmental circumstances into account when planning and developing strategies.
Makes a good first impression and displays a high degree of empathy, trustworthiness, confidence and sturdiness inspiring trust and honesty.
Performs superior leadership in global and dynamic contexts, with strong focus towards relationship building and management, alongside the attraction, recruitment and development of human capabilities in the team.
Inspiration and motivation
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.
Collaborates and works well with others with a view to obtain overall team objectives. Is involving and supporting of team members and shares information.
Works systematically and is highly organized and methodical, while displaying perseverance and consistency towards commenced responsibilities, tasks and projects.
Builds strong and effective organization and champions the philosophy of continuous improvement with a high degree of integrity fostering transparency, reliability and trustworthiness – personally and professionally.
Is able to establish and maintain relations with people at all levels internally as well as externally and make people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks.