Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and regulatory requirements squarely in focus, people who deliver safe and robust solutions.
What you will do:
The Senior Regulatory Affairs/Post Market Surveillance Specialist works to bring medical devices, medicinal products, cosmetics and biocides to market and ensures ongoing compliance for our Sage Products portfolio in EMEA.
Participates on cross-functional teams, collaborates with internal and external business partners to support product expansions globally.
Establishes and maintains a good working relationship with US-based design/manufacturing colleagues and regional RA peers to gain positive & timely support for document preparation.
Determines regulatory requirements, develops regulatory submission strategy and authors regulatory submission documents for product launches and line expansions globally.
Interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes for registration impact
Handles necessary complaint handling process activities for global markets
Determines reportability to the appropriate authority for events that either contributed or could have contributed to adverse events
Submits initial and follow-up reports to regulatory Agencies as needed
Facilitates training on product complaint and adverse event reporting requirements
Supports Post Market Surveillance for EU Medical Devices
Support tender operations by timely supply of accurate regulatory documents
Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction
Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Provides regulatory input and technical guidance on global regulatory requirements to product development teams
Advises stakeholders of regulatory requirements for quality, pre-clinical, and clinical data to meet applicable regulations
Assesses the acceptability of quality, pre-clinical, and clinical document for submission filing to comply with applicable regulations
Evaluates proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
Provides regulatory information and guidance for proposed product claims/labeling
Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
Monitors the progress of the regulatory authority review process through appropriate communications with the agency
Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
What you need:
Bachelor’s degree required with Engineering, Biological Sciences or relevant equivalent experience;
5+ years of Regulatory Affairs experience within medical device, biologics and/or pharmaceutical industries
Understanding of regulatory landscape in EU/EEMEA markets
Ability to understand and explain detailed regulatory compliance issues
Ability to comply with constantly changing regulatory procedures and prioritize work effectively
Ability to analyze and resolve non-routine regulatory issues using independent judgement
Demonstrated analytical, writing and organizational skills
Demonstrated interpersonal, written and oral communication skills
Fluent in English
You might also have:
Working knowledge of the EU Medical Device Regulation
Previous experience with EU Regulatory System for Medicines
Previous experience with EU Cosmetic Products Regulation