Regulatory Analyst managing compliance obligations associated with regulatory requirements at Tallgrass, an energy infrastructure company. Involved in preparation, analysis, and administration in relevant areas.
About the role
- Senior Staff Specialist driving regulatory strategy across the product lifecycle at Stryker. Partnering with cross-functional teams to ensure compliance with global regulatory requirements.
Responsibilities
- Serve as a technical expert and strategic advisor within Stryker’s regulatory organization.
- Drive regulatory strategy across the product lifecycle and partner closely with cross-functional teams.
- Provide deep expertise, influence key decisions, and help shape successful pathways for global market access.
- Develop and evolve regulatory strategies by assessing regulatory intelligence, emerging trends, and changes in global requirements.
- Advise R&D, Quality, Clinical, and Marketing teams throughout the product lifecycle to ensure regulatory compliance.
- Evaluate product concepts, classifications, and regulatory pathways to identify opportunities, risks, and solutions for timely market access.
- Negotiate with regulatory authorities and lead interactions throughout product development, submission, and review.
- Prepare, submit, and track global regulatory submissions in alignment with regulatory guidelines and internal quality standards.
- Assess the impact of proposed clinical, manufacturing, or product changes and recommend regulatory filing strategies.
- Support the development and implementation of new or updated SOPs, processes, and guidance documents to ensure compliance.
- Train and mentor stakeholders on regulatory requirements, expectations, and best practices to enhance organizational capability.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum 6 years of regulatory affairs experience in medical devices or another highly regulated industry.
- Strong knowledge of global regulatory pathways, submission requirements, and product lifecycle management.
- Experience developing regulatory strategies and interacting with regulatory authorities.
- Ability to analyze complex information, exercise sound judgment, and propose actionable solutions.
- Strong communication, collaboration, and stakeholder-influencing skills.
- Ability to manage multiple priorities and operate independently with sound decision-making.
- Master’s degree in Regulatory Science or related field (preferred).
- Regulatory Affairs Certification (RAC) (preferred).
- Experience supporting premarket submissions, post-market activities, and global registrations (preferred).
- Familiarity with clinical investigations, pre-approval inspections, and postmarketing surveillance (preferred).
Benefits
- Flexible working hours model
- Opportunity to work partially from the home office
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Trainee supporting product compliance and legal regulation at ZF, engaging in training activities and various legal assistance tasks. Collaborating with experts on compliance projects.
VAT Compliance Specialist managing VAT - relevant data and ensuring compliance in an international team. Collaborating with various departments to maintain data quality and support documentation processes.
Working Student supporting the VATrules Team with data management and documentation processes. Engaging in VAT compliance and improving data structures in a hybrid work environment.
Specialist II in Regulatory Affairs preparing and maintaining global submissions for conducting clinical investigations. Collaborating with engineering and regulatory teams to ensure compliance with worldwide regulations.
Senior Lead Expert Regulatory managing bank regulatory communication and requirements at leading German bank LBBW. Overseeing compliance, analysis, and decision - making within financial regulatory frameworks.
Regulatory Affairs Manager overseeing compliance of food products and processes. Collaborating with teams to drive regulatory strategies and maintain product quality standards at Bel.
Chief Compliance Officer establishing risk management and compliance frameworks for Sezzle Bank ILC. Managing regulatory compliance and risk in financial services with a focus on BSA/AML and OFAC.
Regional Sustainability Compliance Manager leading product compliance activities across the Americas for ACT Group. Ensuring renewable energy products meet regulatory and sustainability certification requirements.
Legal advisor for cosmetic, animal feed, and tobacco product portfolios based in Darmstadt, Germany. Responsible for product specifications and certifications in compliance with laws.