We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Instruments division based hybrid two to three days per week in Portage, MI.
Who we want
· Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
· 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.
What you will do
As the Senior Staff Regulatory Affairs Specialist, you will support new product development for both domestic and international release contributing to the development and updating of regulatory strategy based upon regulatory changes. You will play an integral role ensuring compliance by completing thorough assessments pertaining to product clearances/approval by the FDA, Notified Bodies, and other regulatory bodies.
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
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
Negotiates with regulatory authorities throughout the product lifecycle
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
Assists other departments in the development of SOPs to ensure regulatory compliance
Provides regulatory input and technical guidance on global regulatory requirements to product development teams
Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
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
Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
What you need
Bachelors Degree required; preferably in Engineering, Science, or related area
RAC preferred
Minimum 6 years of full-time work experience in an FDA regulated environment required
Minimum 4 years of full-time work experience in medical device regulatory affairs required
Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)