Sr. Manager Global Commercial Regualtory Affairs

Radiometer

Bronshoj, Denmark

As our Senior Manager, Global Commercial Regulatory Affairs you will be leading an effort to ensure registration of Radiometers products and providing regulatory guidance and oversight to research, product development, and manufacturing functions during the process of generating the submission(s). You will be responsible for providing technical regulatory leadership and guidance to support new product development as well as existing product platforms. One of your main responsibilities will be to develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards around the Globe. You will also be responsible for interpreting the intent of standards and regulations to provide guidance to project teams and company leadership. Radiometer business is spread across the world, and your team works closely with Regions and Countries like Japan, Korea, Hong Kong, Taiwan, China, SEA, SEE, MENA, APAC, Africa, US, EU, UK, Russia, Canada, LATAM etc.

You will be part of Global RA team consisting of approx. 55 employees located in different parts of the world. You will be located in DK and work with another team member based in the mentioned regions and ensure timely market access of new products as well as maintaining the submissions already in place.

Successful execution of this task depends on cross-functional cooperation with QA, R&D, Production, Sales and Marketing and other departments.

You will also get a chance to work with other Danaher Operating Companies to learn from more established QMS systems

Responsibilities

Direct and facilitate teams of Global Commercial Regulatory Affairs professionals to support global product registrations;
Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission;
Lead and perform internal policy reviews for global regulatory guidance and regulations;
Review changes in international laws and regulations and assess their impact and make recommendations to ensure compliance;
Assesses all requirements and potential obstacles for market access and develops creative solutions to address anticipated obstacles;
Identifies information sources and resources for local, regional, and global regulations;
Track and manage regulatory review timelines and provide updates;
Ensuring archiving and maintenance of submission documentation & correspondence with authorities;
Evaluate applicable laws and regulations to determine impact on organizational activities;
Participate in working groups (MEDTECH or like);
Collects, organizes, and maintains files on local, regional and global regulatory intelligence and other related information;
Ensure trending of feedback from authorities for the purpose of improving processes;
Provide input for management review.

Leadership role

In conjunction with Regulatory Affairs department leadership, ensure optimal acceptable regulatory strategies for worldwide compliance and obtaining & maintaining product licenses;
Responsible for parts of the regulatory function and activities and strategy related to this;
Responsible for providing input to the functional strategy and help ensure implementation of this;
Responsible for driving projects and priorities as per the function and company objectives;
Provides leadership to professional associates, sets departmental priorities and allocates resources to align with business objectives and annual plan;
Develops departmental plans, including business, production and/or organizational priorities;
Ensuring associate have the appropriate skills and training and accountable for the performance and results of multiple related teams;
Establish organizational guidelines, policies or standard work to establish clear documented work paths through DBS tools;
Coordinate complex logistical details including team resourcing and project timeline planning; liaise with functional stakeholders.

Requirements

Formal Education

The preferred candidate holds a Master’s Degree, PhD, or Doctorate in Science, Engineering, Pharmacy, Biology, Biochemistry or the like.

Competencies

Minimum of 10+ years of related work experience with at least 8 years working in Regulatory Affairs and/or directly supporting functions;
5+ years leadership experience;
Regulatory compliance experience;
Well-developed regulatory technical knowledge and skills;
Having compiled, prepared, reviewed, and successfully submitted regulatory submissions to MDSAP and globally;
Interacted with regulatory agencies/health authorities/authorized representatives to obtain and maintain product approvals;
Supported design changes and sustainment projects;
Experience with In vitro diagnostics will be preferred;
Detailed knowledge of EU MDD/MDR/IVD/IVDR requirements;
Proven success in 510(k) or PMA authoring resulting in clearance/pre market approval;
Proven success interacting with regulatory agency personnel;
Experience in working with clinical and R&D projects;
Successful experience taking a product from development through to global regulatory approval;
Promotional item and labeling approval experience.