Danaher Corporation Senior Regulatory Affairs Manager in Dubai, United Arab Emirates
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.
We are looking for aSenior Regulatory Affairs Manager inDUBAIaccording to the following :
Report to:Head Regional RA
Scope: Turkey, Middle East & Africa
- Be knowledgeable of the local regulatory requirements. Keep abreast of the regulatory changes and trends in assigned geographies. Keep RA Teams and local business leaders and local distributors informed in a timely manner on emerging regulatory issues and develop strategies to mitigate regulatory risks.
- Provide regulatory strategies for new product introductions and product changes, and assist in maintaining regulatory compliance in targeted markets to drive competitive advantage.
- Maintain transparent oversight of all regulatory activities. Monitor the progress, status and timelines of submissions, including global KPIs as requested.
- Maintain registration licence database and of local regulatory requirements.
- Maintain oversight and keep control of all costs related to registrations, including regulatory consultants and other activities.
- Work closely with other RA teams to translate regional/global regulatory strategies into executable local plans. Identify gaps that may impact implementation.
- Monitor regional regulatory environment and look for opportunities to shape future regulations, guidance, policy and legislation.
- Review and validates marketing and labeling materials for countries in scope
- Support local post-market surveillance activities such as customer complaints, adverse events, and field safety corrective actions (FSCA) including product recalls, as needed for countries in scope
- Manage RA/QA partners screening and periodic review process using Channel Partner Toolkit (CPTK)
- Establish and build on relationships with key contacts within the organization to support the countries, thereby ensuring strong relationship with the industry associations, regulatory agencies and with external stakeholders.
- A minimum of a Bachelor’s degree from accredited college or university is required. A Master’s degree or PhD is of advantage. A degree focused in technology or science is preferred.
- Minimun 7-10 years experience in Regulatory Affairs. Thorough understanding of regulatory requirements for medical device products industry.
- In-depth knowledge of regulations and regulatory environment for countries in scope.
- Proven track record of successfully managing regulatory projects in region
- Experience in reviewing, interpreting changing legislation and implementing it successfully in processes and procedures.
- Ability to translate knowledge of regulatory guidelines and requirements into action plans, in particular in changing and uncertain regulatory environments
- Ability to summarize succinctly regulatory project status, critical issues and impact
- Excellent communication skills, including strong interpersonal / negotiation skills
- Good organizational & time management skills, must be self motivated and detailed oriented
- Strong cultural awareness and sensitivity
- Language Skills: Arabic & English mandotory. French will be a plus.
- Ability to act as single contributor as well as lead a team to ensure RA action plans are delivered on time
- Ability and willingness to lead and work in a complex matrix environment with direct & indirect reporting relationships
- Proficiency in MS Office, MS Sharepoint, Excel and Adobe Acrobat
Danaher Corporation Overview
Danaher's Dental Platform is a $3B global business focused on all aspects of dental care. With the intention to spin-off the Dental Platform to become its own public company in the second half of 2019, “Dental Co” will become one of the largest and most innovative dental companies in the world. We are changing the face of dentistry with our differentiated portfolio of products designed to serve every dental professional’s need. It is our mission to make our dentist's work simpler and better connected so more patients are cared for in a shorter time. Our dental brands include traditional consumables and equipment (KaVo Kerr) and specialty products (Ormco and Nobel Biocare).
Organization: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Middle East/Africa (MEA)-AE-DU-Dubai
Req ID: NOB002884