Regulatory Affair Manager

About the role

As a Regulatory Affairs Manager at Newel Health, you will play a pivotal role in ensuring that our products meet all regulatory requirements and standards. You will be responsible for overseeing the regulatory strategy and compliance processes, facilitating the approval of new products, and maintaining the integrity of existing product lines. This position requires a keen understanding of the regulatory landscape and the ability to navigate complex guidelines to ensure that our innovations are brought to market efficiently and safely.

Key facts

What you'll do

• Develop and implement regulatory strategies for new product development and existing product maintenance to ensure compliance with local and international regulations.
• Prepare and submit regulatory documentation, including but not limited to pre-market notifications, product registrations, and compliance reports to relevant authorities.
• Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure that regulatory considerations are integrated into product development processes.
• Monitor changes in regulations and industry standards, providing guidance to internal teams to ensure ongoing compliance.
• Conduct risk assessments and prepare regulatory submissions to mitigate potential compliance issues.
• Act as a liaison between Newel Health and regulatory agencies, facilitating communication and addressing any inquiries or concerns.
• Lead internal audits and inspections to evaluate compliance with regulatory requirements and implement corrective actions as necessary.
• Provide training and support to team members on regulatory processes and compliance best practices.
• Maintain comprehensive records of regulatory submissions and correspondence to ensure traceability and accountability.
• Participate in the development of product labeling and promotional materials to ensure compliance with advertising regulations.
• Prepare and present regulatory updates to senior management and stakeholders to keep them informed of compliance status and potential impacts on business operations.
• Support the development of standard operating procedures (SOPs) related to regulatory affairs to enhance operational efficiency.

Requirements

• Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in regulatory affairs within the healthcare or pharmaceutical industry.
• In-depth knowledge of regulatory requirements and guidelines, including FDA, EMA, and other relevant authorities.
• Proven track record of successful regulatory submissions and approvals.
• Strong analytical and problem-solving skills with the ability to interpret complex regulations.
• Excellent communication skills, both written and verbal, with the ability to convey technical information to non-technical stakeholders.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.

Nice to have

• Experience with medical devices or combination products is a plus.
• Familiarity with quality management systems (QMS) and ISO standards.
• Previous experience in a leadership role within a regulatory affairs team.
• Knowledge of global regulatory requirements beyond the US and EU markets.
• Certification from a recognized regulatory affairs organization (e.g., RAC) is advantageous.

Skills & tools

• Proficient in regulatory submission software and document management systems.
• Familiarity with project management tools to track regulatory timelines and deliverables.
• Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and presentations.
• Ability to utilize data analysis tools to support regulatory decision-making processes.

Practical notes

• The position is based in an undisclosed location, and candidates should be prepared for potential relocation.
• Newel Health offers competitive compensation and benefits, including health insurance, retirement plans, and opportunities for professional development.
• Visa sponsorship is available for qualified candidates, making this an excellent opportunity for international applicants.
• Interested candidates can apply through the following link: https://newelhealth.bamboohr.com/careers/142.

At Newel Health, we are committed to fostering an inclusive and diverse workplace. We encourage applications from individuals of all backgrounds and experiences who are passionate about making a difference in the healthcare industry. Join us in our mission to innovate and improve health outcomes for patients around the world.