Regulatory Specialist Jobs

About The Position

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• 3–4 years of experience in a regulated industry, such as medical products or nutritionals.
• 2–3 years of regulatory experience preferred; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may be considered.
• Ability to communicate effectively, prepare materials, and negotiate internally and externally with regulatory agencies.
• Effective verbal and written communication skills.
• Ability to work in a highly matrixed and geographically diverse environment.
• Broad knowledge of technical alternatives and their potential business impact.
• Good and ethical judgment within applicable policies and regulations.
• In-depth knowledge of business functions and cross-group dependencies and relationships.
• Ability to define regulatory strategy with supervision.
• Ability to follow scientific arguments, identify regulatory scientific data needs, and resolve regulatory issues with supervision.

Nice To Haves

• Master’s degree in Regulatory Affairs, which may be used in lieu of direct regulatory experience.
• 5+ years of experience in the medical device industry.
• 3–5 years of regulatory experience.
• Analytical thinking and good problem-solving skills.
• Experience with 510(k), PMA, or other international regulatory submissions.
• Regulatory certification, such as RAC from the Regulatory Affairs Professionals Society.

Responsibilities

• Assist with the development and review of standard operating procedures and provide regulatory input to product lifecycle planning.
• Compare regulatory outcomes with initial product concepts and recommend future actions.
• Assist in developing regional regulatory strategies and update strategies in response to regulatory changes.
• Investigate regulatory history and relevant disease, therapeutic, or diagnostic context to assess approval implications and anticipate regulatory obstacles.
• Determine and communicate submission and approval requirements, and participate in risk-benefit analyses for regulatory compliance.
• Monitor changing regulations and their effect on submission strategies, applications under review, and applicable regulatory reports.
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
• Interact and negotiate with regulatory authorities during development and review to support submission approval.
• Maintain annual licenses, registrations, listings, and patent information.
• Obtain US and EU post-market change approvals or clearances and coordinate related submissions and approvals with international affiliates.
• Independently draft US and EU post-market change submissions and deficiency responses.
• Submit and review change controls, determine change levels and resulting submission requirements, and analyze cumulative product changes against current submissions.
• Contribute to the crisis and issue management program.
• Ensure product safety issues and product-associated events are reported to regulatory agencies and provide regulatory input for product recalls and recall communications.
• As applicable, support medical writing, advertising and promotion, labeling, controlled or restricted substances, compendial standards, import/export, country-specific regulatory matters, and animal tissue documentation.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor’s degree.