Regulatory Affairs Specialist (Project Management)
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 all regulatory requirements, commitments, and agreements. May review complex 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 pathways 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 related.
Work Experience
2 years of experience in medical device regulatory affairs or quality assurance.
Knowledge / Skills / Abilities
Understanding of the current Regulatory environment and demonstrating the ability to perform within.
Applied knowledge of FDA regulations and guidelines.
Ability to evaluate information to determine compliance with standards, laws, and regulations.
Travel required up to 5%.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$72,280.00 - $105,040.00 AnnualThe actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline 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.
Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
