Regional Ra Director

1 week ago

Central Singapore Emprego SG Full time

**Location**
- Singapore, Central Singapore**Job Type**
- Permanent**Salary**
- $18,000 - $21,000 Per Month**Date Posted**
- 4 hours agoAdditional Details

**Job ID**
- 110896**Job Views**
- 1Roles & Responsibilities

Who We Are

About the role

Leads regional RA team as RA business partners and strategic regional projects. Works closely with VP, Regulatory Affairs, Greater Asia in executing regional Regulatory Affairs strategy and supporting Greater Asia countries.

Role Responsibilities:

- Provide oversight of regional RA team in business partnership with regional business and functional stakeholders:

- Provide RA support and strategies across all BUs and countries
- Identify and implements process improvement opportunities
- Lead GA EUMDR/IVDR program with 2 workstreams: business continuity and plant compliance:

- Responsible for overall project deliverables including business continuity and project budget
- Establish governance structure; roles and responsibilities; planning process; etc.
- Identify road blocks and drive for resolution; coordinate change registration strategy between WW BU RA and country RA
- Lead and execute planning; fine-tune processes; escalate potential red flags; etc.
- Provide regular updates to management
- Regional leader of corporate and functional key projects. Set strategy and drive implementation in Greater Asia.
- Establish initial scope for budget & resource planning
- Provide guidance to Greater Asia country associates for resolution and identify potential risks
- Formulate and implement initiatives to shape regulatory affairs into a best-in-class, more digitally savvy and future fit function.
- Anticipate new regulations that could impact the business and keep abreast of regulatory changes in GA countries. Support countries in minimizing business risks and provide regional businesses with assessments and mitigations.
- Provide guidance and oversight to Tuas plant RA associate on various aspects:

- Strengthen RA partnership with plant steering committee and other stakeholders - initial focus is on regulatory actions resulting from ACR / NoC and the impact to plant’s operations and targets.
- RA support on corporate audit; new initiatives like MDSAP certification; etc.
- Talent development and associate engagement improvement of Regional RA team.
- Complies with all government and BD regulations/policy/procedures.

**Qualifications**
- Minimum 10 years in a leadership regulatory affairs role in Asia
- Familiarity with Asian country regulations particularly China and Japan regulations
- Interaction and advocacy with Asian country authorities
- Knowledge of international regulations and key standards such as EU MDR/IVDR, MDSAP, ISO13485, etc.
- Experience in implementation of digital solutions, innovation and process improvements
- Experience in business partnering with strong business acumen
- Experience in people management and talent development
- Excellent communication and persuasion skills

Culture and Benefits

Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

How To ApplyTags

regional

ra

director

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