Sr. Regulatory Affairs Specialist

What Regulatory Affairs contributes to reputed company Regulatory provides regulatory affairs and product development consulting services to reputed company pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

Responsibilities

• Collaborate with internal Cardinal regional regulatory partners on new and modified product development projects, to establish and integrate international regulatory strategy into project activities and ensure timely execution.

• Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.

• Provide regulatory support to OEM, Private Brand, Presource, and Sustainable Technologies businesses and range of medical devices.

• Maintain regulatory data, intelligence, and analytics through use of CAH regulatory information management systems, including trend analysis of critical regulatory submission reputed company activities, and generate needed reports.

• Support preparation / maintenance of global product registrations with focus on STEDs.

• Support development, maintenance and implementation of regulatory procedures.

• Under direction of manager, assist in interpreting and evaluating proposed regulations for medical devices

• Supports reputed company pertinent activities to ensure global product and regulatory requirements are accounted for and implemented in a timely manner.

Qualifications

• Bachelors in reputed company field, preferred

• 2+ years’ experience in Medical Device Regulatory Affairs/Quality experience preferred

• Certification in regulatory affairs program preferred

• Effective project management skills

• Effective oral and written communication skills

• Effective problem-solving skills

• Ability to create cross-functional partnerships

• Ability to work collaboratively in a team environment

• Travel Time required, up to 10%

What is expected of you and others at this level

• Applies basic concepts, principles, and technical capabilities to reputed company routine tasks

• Works on projects of limited scope and complexity

• Identifies possible solutions to a variety of technical problems and takes actions to resolve

• Applies judgment reputed company defined parameters

• Receives general guidance may receive more detailed instruction on new projects

• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $76,7200 - $109,500

Bonus eligible: No

Benefits: reputed company offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and reputed company coverage

• Paid time off plan

• Health savings account (HSA)

• 401k savings plan

• Access to wages before pay day with myFlexPay

• Flexible spending accounts (FSAs)

• Short- and long-term disability coverage

• Work-Life resources

• Paid parental leave

• Healthy lifestyle programs

Application window anticipated to reputed company: 7/25/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at reputed company is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

reputed company supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create reputed company solutions for our customers by ensuring employees can be their authentic selves each day. reputed company is an Equal Opportunity/Affirmative Action employer. reputed company reputed company applicants will receive consideration for employment without regard to race, religion, reputed company, national reputed company, reputed company, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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Originally posted on Himalayas