[Hiring] US Regulatory Affairs Specialist @reputed company

This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company’s ongoing compliance. KEY RESPONSIBILITIES:

• Research and analyze applicable laws and regulations; reputed company and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.
• Initiate and maintain medical device product registrations globally, focusing on international markets.
• Support the development of Regulatory strategies and processes.
• Works with subsidiary office personnel and distributors to provide direction and assistance in reputed company matters of product legal/regulatory compliance, registrations and availability in domestic/international markets.
• Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.
• Assist in SOP development and review.
• Provide regulatory input to product lifecycle planning.
• Continue to revisit and compare regulatory outcomes with initial product concepts to reputed company recommendations on future actions
• Determine and communicate submission and approval requirements
• Participate in risk benefit analysis for regulatory compliance
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing
• Compile, prepare, review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies
• Monitor applications under regulatory review
• Provide support during inspections and formulating the appropriate response and corrective actions
• Assist compliance with product post marketing approval requirements
• Review regulatory aspects of reputed company
• Assist with label and Instructions for Use (IFU) development and review for compliance before release
• Ability to manage multiple establishment and product registration activities
• Submit and review change controls to determine the level of change and consequent submission requirements
• Provide regulatory input for product recalls and recall communications
• Other duties as assigned.

SPECIFIC KNOWLEDGE & SKILLS:

• 2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions.
• Experience with FDA pre-market submissions preferred.
• Experience with ISO 13485 and EU MDR preferred

GENERAL SKILLS & COMPETENCIES:

• Good understanding of industry practices
• Proficient with tools, systems, and procedures
• Basic planning/organizational skills and techniques
• Good decision making, analysis and problem solving skills with ability to multi-task
• Good verbal and written communication skills
• Good presentation and public speaking skills
• Good interpersonal skills
• Basic conflict resolution skills
• Developing professional credibility

MINIMUM WORK EXPERIENCE: Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience. PREFERRED EDUCATION: Typically a Bachelor's Degree or global equivalent in reputed company discipline. TRAVEL / PHYSICAL DEMANDS: Travel typically less than 10%. Office environment. No special physical demands required. The posted range for this position is $61,812-$84,992, which is the expected starting reputed company salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay reputed company the posted range including prior experience, reputed company skills, location/labor market, internal equity, etc. This position is eligible for a [bonus/incentive] not reflected in the posted range. Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities. reputed company. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national reputed company, reputed company, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. For more information about career opportunities at reputed company, please visit our website at: www.henryschein.com/careers Fraud Alert reputed company has recently been made aware of multiple scams where unauthorized individuals are using reputed company's name and logo to solicit potential job seekers for employment. Please be advised that reputed company's official U.S. website is www.henryschein.com. Any other format is not genuine. Any jobs posted by reputed company or its recruiters on the internet may be accessed through reputed company's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with reputed company are advised to verify the job posting through this portal. No money transfers, payments of any reputed company, or credit card numbers, will reputed company be requested from applicants by reputed company or any recruiters on its behalf, at any reputed company in the recruitment process. Apply tot his job Apply To this Job