Regulatory Affairs Director, International
An awesome client of ours is looking for you to contribute with your regulatory skills to the innovation of Clients products focusing on improving nature sustainability. You and your operations team in collaboration with regulatory/ Q&R team in the markets, have strong interaction with innovation teams on Regulatory Affairs matters.
You are part of the team, and part of International Regulatory affairs team and will be reporting to Chief Commercial Officer, International Markets.
You are responsible for:
- Enabling all regulatory activities necessary to facilitate speed-to-market and to achieve all regulatory timelines and milestones as per international business plans and company's objectives.
- Developing and implementing regional regulatory strategies and processes to support the timely registration of, new products, major changes and life cycle management.
- Coordinate with COO and Regulatory Affairs team and with Q&R head and lead regulatory affairs specialists in the countries under the scope to ensure to ensure optimal, efficient and compliant registration.
- Lead and drive regulatory activities in accordance with local and international requirements to ensure on time products registration or life cycle management in the markets in scope of responsibility.
- Responsible for Regulatory monitoring and analysis of new or updated local legislation and for assuring in-time registration in the local market (country).
- Create with innovation teams a regulatory plan and a labelling plan (when needed) to ensure consistency and guidance to the market introduction projects.
- Ensure product compliance by executing the regulatory plan and reviewing all relevant compliance evidence.
- Identify potential regulatory approval risks based on regulations, standards, country-specific issues or other unique characteristics.
- Recommend strategies to the business on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive implementation and resolution.
- Represent the organization in local or regional standard- committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization,
- Consult with product and solutions teams to ensure timely, effective and efficient transition to new requirements. Mentor and train others to effectively do the same.
- Share's knowledge and is able to guide and mentor others about regulatory best practices and registration standards for regulatory approvals and post-market needs.
You will be part of:
The international regulatory management team with members in international/ regional markets.
To succeed in this role, you should have the following skills and experience:
- Master degree (Engineering or Medical / biomedical background)
- >10 years of experience in Regulatory Affairs at International level
- Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must,
- Experience in Project management within Regulatory Affairs is preferred,
- FDA , TGA and EU MDD, CE marking experience is a plus,
- Comprehensive knowledge of environmental permit regulations is a must, including MCAN (Microbial Commercial Activity Notice). Proven leadership experience of people and large scale projects.
- RAPS Certified is a plus,
- Strong communicative and stakeholder management skills,
- Fluent in English. Additional language is a plus,
- Strong leadership skills,
- Organized, details oriented, decision making,
- Managing priorities,
- Business partner and account manager capabilities,
- Influencing and consulting skills,
- To be able to work in a constant changing environment,
- Comfortable with business travelling up to 20% regionally
- Act with Integrity,
- Must be self-motivated