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About the Role
This role involves assessing regulatory intelligence, developing regulatory strategies, and ensuring product compliance throughout the product lifecycle. You will evaluate the regulatory environment, anticipate obstacles, and provide guidance to cross-functional teams and regulatory authorities.
Responsibilities
- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- Participate in advocacy activities of a more advanced technical, tactical, or strategic nature.
- Evaluate the regulatory environment and contribute to internal advice throughout the product lifecycle to ensure product compliance.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
- Identify requirements and potential obstacles for market access distribution.
- Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
- Evaluate proposed products for regulatory classification and jurisdiction.
- Determine requirements and options for regulatory submission, approval pathways, and compliance activities.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle.
- Compare regulatory outcomes with initial product concepts and recommend changes or refinements.
- Negotiate with regulatory authorities throughout the product lifecycle.
- Identify the need for new regulatory procedures, SOPs, and participate in their development and implementation.
- Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Assist other departments in the development of SOPs to ensure regulatory compliance.
- Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
- Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Assess the acceptability of quality, preclinical, and clinical documents for submission filing.
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategize for changes that do not require submissions.
- Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
- Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
- Provide regulatory information and guidance for proposed product claims/labeling.
- Ensure that clinical and nonclinical data are consistent with regulatory requirements and support proposed product claims.
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitor the progress of the regulatory authority review process through appropriate communications with the agency.
- Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission.
- Work with cross-functional teams for interactions with regulatory authorities, including panel meetings and advisory committees.
Requirements
- BS in Engineering, Science, or related degree; or MS in Regulatory Science.
- Typically a minimum of 6 years’ experience.
- MS or RAC(s) preferred.
- Technical and management skills and engaged in regulatory strategy and operations.
- Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution.
- Under general supervision, plan, conduct and supervise assignments.
- Review progress and evaluate results.
- Recommend changes in procedures.
- Operate with appreciable latitude for unreviewed action or decision.
- Review progress with management.
- May direct work of Specialist or Sr. Specialist.
- Seek out diverse ideas, opinions, and insights and apply them in the workplace.
- Connect and relate well with people who think and act differently than oneself.
- Embrace scrutiny and accept feedback as an opportunity to learn and improve.
- Choose the best alternative to achieve a desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources.
- Navigate the dynamics, alliances, and competing requirements of the organization or business.
- Willingly accept challenging assignments and new career opportunities that stretch and build capabilities.
Skills
- Regulatory strategy
- Regulatory operations
- Regulatory pathways
- Risk-benefit analysis
- Communication
- Collaboration
- Submission
- Registration
- Approval
- Documentation
- Compliance
- Postmarketing surveillance/vigilance
- Distribution
Location
- Hybrid
- Onsite
Work Type
- Hybrid
- Onsite
Experience Level
- Minimum of 6 years’ experience
Education Level
- BS in Engineering, Science, or related degree
- MS in Regulatory Science
- MS or RAC(s) preferred