Regulatory Strategy Lead
About the Role
This is a key position that oversees regulatory affairs strategy, driving compliance and efficiency across our operations.
Key Responsibilities
* Develop and implement global regulatory strategies, aligning them with business objectives.
* Collaborate with cross-functional teams to integrate regulatory considerations into product development and entry/exit strategies.
* Analyze regulatory pathways and recommend changes based on outcomes.
* Lead negotiations with regulatory authorities throughout the product lifecycle.
* Establish relationships with government and non-government organizations affecting market access and distribution.
* Manage new regulatory procedures and standard operating procedures.
Requirements
* Bachelor's degree in science, engineering, or related field; advanced degree preferred.
* Minimum of 8 years of experience.
* RAC certification desired.
* Proven ability to lead cross-functional teams and collaborate effectively.
* Experience managing multiple projects and reporting trends and analysis.
Skills and Competencies
* Strong knowledge of regulatory requirements, including ISO, FDA, and international standards.
* Technical knowledge of medical device product lines.
* Excellent communication, listening, and team-building skills.