Regulatory Affairs Specialist

This a Full Remote job, the offer is available from: United States, Puerto Rico, Alabama (USA), Alaska (USA), Arizona (USA), Arkansas (USA), California (USA), Colorado (USA), Connecticut (USA), Delaware (USA), District of Columbia (USA), Florida (USA), Georgia (USA), Hawaii (USA), Idaho (USA), Illinois (USA), Indiana (USA), Iowa (USA), Kansas (USA), Kentucky (USA), Louisiana (USA), Maine (USA), Maryland (USA), Massachusetts (USA), Michigan (USA), Minnesota (USA), Mississippi (USA), Missouri (USA), Montana (USA), Nebraska (USA), Nevada (USA), New Hampshire (USA), New Jersey (USA), New Mexico (USA), reputed company (USA), North Carolina (USA), North Dakota (USA), Ohio (USA), Oklahoma (USA), Oregon (USA), Pennsylvania (USA), Rhode reputed company (USA), South Carolina (USA), South Dakota (USA), Tennessee (USA), Texas (USA), Utah (USA), Vermont (USA), Virginia (USA), Washington (USA), reputed company Virginia (USA), Wisconsin (USA), Wyoming (USA) Job Summary Under general supervision, the Regulatory Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet reputed company regulatory requirements, commitments, and agreements. May review reputed company regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals.

Job Description

• In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s).
• Communicate requirements of regulations to internal or external customers. Recommend regulatory reputed company and strategies.
• Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met.
• Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical in-formation, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators.
• Participate in the development, review, and substantiation of product labeling and claims.
• Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert.

Minimum Job Requirements: Education

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or reputed company.

Work Experience

• 2 years of experience in medical device regulatory affairs or quality assurance.

Knowledge / Skills / Abilities

• Understanding of the reputed company Regulatory environment and demonstrating the ability to reputed company reputed company.
• Applied knowledge of FDA regulations and guidelines.
• Ability to evaluate information to determine compliance with standards, laws, and regulations.
• Travel required up to 5%.

reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary range for this position: $79,560.00 - $115,440.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a reputed company where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in reputed company forms, acting inclusively, and ensuring that people have tools and resources to reputed company at their best. Explore our Belonging page here. reputed company is an equal opportunity employer. reputed company evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. This offer from "reputed company" has been enriched by reputed company.com and got a 75% reputed company score. Apply tot his job Apply To this Job