RB
The Regulatory Manager delivers innovative solutions for healthier lives and happier homes, RB is in the top 20 of companies listed on the London Stock Exchange. Today it is the global No 1or No 2 in the majority of its fast-growing categories, driven by an exceptional rate of innovation. Its health, hygiene and home portfolio is led by 19 global Powerbrands of Nurofen, Strepsils Gaviscon, Mucinex, Durex, Scholl, Clearasil, Lysol, Dettol, Veet, Harpic, Bang, Mortein, Finish, Vanish, Calgon, Air Wick, Woolite and French's. 80% of core revenues came from the health and hygiene categories of the portfolio.
Key Responsibilities Advanced ability to interpret and apply regulations and guidance.
Mentor and direct others in their understanding and application of regulations and guidance.
Lead the development and implementation of global regulatory strategies for medical devices and combination products.
Serve as a medical device and combination product regulatory subject matter expert.
Responsible for oversight of responses to Regulatory agency questions.
Acts as RB lead with Regulatory Agencies during product negotiations; applies gained knowledge and experience to increasingly complex regulatory issues. Shares knowledge and experience with peers.
Leads team to achieve targets, balance resources, quality and speed to market. Sets clear priorities, reviews project progress and is able to provide gap analysis and resolutions. Applies best practice Project Management methods, anticipating contingencies and builds-in team response and readiness in advance.
Oversee and consult on the development of submission strategies for basic/routine projects. Responsible for submission strategy development and execution for projects in collaboration with R&D and PO1 teams. Leads team to achieve targets for integration activities and plans/manages external projects that may arise throughout the year.
Departmental representative on RB system development projects. Mentors others on the functionality of these resources. Responsible for reviewing and approving departmental SOP/work practices.
Is this You?
- BA/BS degree required in the natural sciences.
- 8 - 12 years of relevant work experience required.
- 3+ years of prior line management experience a plus.
- Experience with FDA registered products, class 2 medical devices and 510(k) required.
- Prior experience working in the Pharmaceutical, CPG, and/or Healthcare industry required
- Solid knowledge of Regulatory Agency organizations.
- High attention to detail and strong organization skills.
- Ability to establish close communications and working relationship with cross functional teams to meet business objectives.
- Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements.
- Strong verbal and written communication skills.
- Strong negotiating, influencing and interpersonal skills.
- Results oriented, entrepreneurial and self-motivated.
Why RB?
Fast paced. Tired of having to jump through endless hoops to get things done? Not here. We move fast and deliver.
Growth. Frustrated by the lack of growth opportunities in your current company? Not here! RB takes pride in the development and continued growth of our employees through steady rotations and promotions.
Autonomy. RB empowers you to OWN what you do.
Iconic Global Brands. Take a look. You'll be surprised at how many you already have in your home.
Feel good about the company you work for! RB is committed to making the world a better place through betterbusiness.
Passport Stamps. Does working Internationally interest you? Perform well and Global doors can open for you at RB.
Work with smart people. We have a talented workforce that believes in sharing ideas to help each other, and the company succeed.
Vacation. We offer 4 weeks' vacation, 9 core Holidays and 4 floating days.
16 weeks paid Maternity leave.
Competitive base salaries and bonuses.
Tuition reimbursement.
In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.
Apply Now for a chance to really change the game!
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
