Regulatory Affairs Manager

**Description**:
**Join a team that is changing millions of lives.**

Transforming smiles. Transforming lives. Transforming an industry.

At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our teams are constantly pushing the boundaries of what’s possible.

Ready to join us?

**About this opportunity**

The APAC Regulatory Affairs Department has a position in Singapore**for a Regulatory Affairs (RA) Manager to support these local & regional functions of the Department. The role is to oversee and focus on regulatory submissions, quality management system and government affairs efforts in South East Asia (SEA) and to overall support the **Director, International Regulatory Affairs, APAC**in achieving the department goals from a local level, cascading to APAC level. This Manager role needs to provide oversight on the guidance and recommendations to other country business stakeholders on SEA’s requirements, in particular Singapore, Vietnam, Malaysia, Indonesia and Philippines, and ensure compliance to accepted practices. This position is also responsible for supporting development of SEA’s regulatory strategies for local submissions and registrations, working in tandem with Corporate RAQA and R&D program teams for design input and regulatory assessments. Help to proactively drive Align’s agenda by engaging with applicable regulatory agencies and to ensure relationship building.

**In this role, you will**

**Regulatory Affairs**
- Represent Align’s policy interests in SEA as agreed with APAC RA Department, the site leadership team and U.S. headquarters.
- Responsible for ensuring the compliance with Singapore, Vietnam, Malaysia, Indonesia and Philippines medical device regulations; to conduct impact assessment, develop rationale and documentation for new product and product changes.
- Develop regulatory strategies for local submissions and registrations, working in tandem with Corporate RAQA and R&D program teams for design input and regulatory assessments.
- Work collaboratively with APAC RA, project teams and U.S. headquarters, to prepare and submit regulatory submissions to regulatory bodies and/or notified bodies and/or applicable regulatory agencies for new or change submissions.
- Ensure that annual or time limited product approvals/site licenses are renewed/maintained to ensure product supply.
- Conduct post market obligations and coordinate with APAC RA and U.S. headquarters to ensure timely reporting of adverse events.
- Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align, propose action plans to APAC RA and see through agreed plans.

**Others**
- Provide administrative support to **Director**, **International Regulatory Affairs, APAC** including but not limited to collation of Global Regulatory Impact Assessments (GRIA).
- Assist with all department projects as required.
- Participate in proactive team efforts to achieve departmental and company goals.
- Provide support to audit processes and quality management system as required.

**In this role, you’ll need **
- Proficient in English.
- Must understand the regulatory requirements for medical devices in SEA.
- Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
- Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
- A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
- Must be able to work independently, and handle both small and large matters with equal effectiveness and enthusiasm.
- Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change.

**EDUCATION and/or EXPERIENCE**
- Bachelor Degree in Science or Engineering preferred.
- 3-5 years of experience in Regulatory Affairs and Quality Assurance role at medical device company is required.
- Thorough understanding of SEA’s medical device laws and regulations.
- Experience in performing all regulatory functions (e.g., writing submissions, reviewing documentation for regulatory compliance, interfacing with regulatory agencies, etc.) and medical device, software-related regulatory requirements.
- Significant experience within the legislative and regulatory fields applicable to medical devices, including interaction with government officials.
- Experience in performing QMS functions to comply with local requirements.
- Able