Regulatory Affairs Manager, IBD
Position is virtual but candidate must reside in the Orange County, CA or in the Boston, MA area. The Regulatory Affairs Manager will need to be on site at our San Juan Capistrano, CA or Marlborough, MA lab one day per week.
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. Additionally, this individual will provide leadership and guidance to the Regulatory team on regulatory matters.
Essential Duties and Responsibilities:
• Oversee US and/or Global product registration submissions. This includes, but is not limited to: PMA, 510ks, DeNovo, International dossiers and/or CE technical files.
• Interprets applicable standards, regulations and directives to ensure Regulatory compliance.
• Formulate and establish clear objectives and work plans; review progress against objectives and establishes countermeasures, where necessary, to achieve success.
• Complete regulatory assessments of product modifications and develop regulatory strategies for new products.
• Interact with regulatory agencies as part of submission review and on-site audit support.
• Review regulatory content for claims support of promotional material, labeling content, product and process changes, and product documentation.
• Lead by providing the motivation and inspiration to work effectively toward organizational goals and the individual objectives for reaching the goal.
• As applicable, supervise Regulatory team with daily tasks, while providing guidance on Regulatory matters.
• Ensures resources and activities are aligned with the company objectives. Effectively communicates progress, problems, and plans.
• Foster and maintain strong relationships with senior RAQA Regulatory leaders across the company and leverage best practices and opportunities to drive cross business collaborations and initiatives.
• Implements company goals and objectives as related to areas of responsibility, and sets Regulatory goals and objectives for the Regulatory team.
• Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management.
• Track timelines and document milestones for inclusion in regulatory submissions.
• Support implementation of new policies by serving as RA subject matter expert.
• Develop, review and support maintenance of regulatory SOPs.
• Collaborate with cross-functional teams.
• Perform special projects as needed.
Domestic and/or International
Able to lead teams and perform as a team member, superior communications and excellent interpersonal relationship abilities.
- Bachelor's Degree (BA/BS) from four-year college/university required.
- Four to six years related experience and/or training in an FDA-regulated industry.
- A minimum of 7 years of related experience is required with a Bachelor’s degree, OR, a minimum of 5 years of related experience is required with a Master’s degree.
- Supervisory or project team leadership experience is desired.
- Excellent oral and written communication skills, including the ability to discuss regulatory strategy and requirements with senior management.
- Exceptional attention to detail.
- Enthusiastic team player with an ability to collaborate with diverse teams.
- Exceptional time management and organizational skills.
- Strong ability to problem solve and apply analytical thinking.
- Ability to manage conflict resolution.
- Ability/Awareness of the importance of workplace diversity. Understand the gaps and differences that exist as well as their impact.
Well-developed technical writing skills including presenting technical information in the context of regulatory requirements. Strong listening skills. Communications with regulatory bodies on significant matters, including formal response to regulators on submissions, with minimal supervision.
Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Strong computer skills in Word, Excel and PowerPoint
Certificates, Licenses, Registrations:
RAC certification desired.
Other Skills and Abilities:
Ability to effectively translate regulatory requirements into practical advice to cross-functional teams and other audiences. Crisp decision-making capabilities, delegation, managing to tight deadlines, prioritization of work for self and subordinates.